CLASS II Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report

Nandrolone Decanoate (h) 200mg/ML Injectable recalled

Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Nandrolone Decanoate (h) 200mg/ML Injectable, distributed nationwide in the US. The recall was initiated on 21 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRx #'s: C0371167 C0371185 C0371187 C0371193 C0381331 C0381336 C0381348 C0381353 C0381360 C0381364 C0381366 C0381371 C0384632 C0384634 C0384637 C0389199 C0389200 C0389201 C0389205 C0389216 C0389219 C0389223 C0389224 C0392398 C0392399 C0392401 C0392405 C0392407 C0392409 C0392410 C0392411 C0392412 C0392414 C0392418 C0392419 C0392421 C0392426 C0392429 C0392433 C0392434 C0392435 C0392436 C0392438 C0392441 C0394169 C0394170 C0394171 C0394172 C0394173 C0394174 C0394175 C0394176 C0394177 C0394178 C0394179 C0394180 C0396357 C0396362 C0396365 C0396370 C0396374 C0396377 C0396388 C0396397 C0396398 C0397477 C0397478 C0397479 C0397481 C0397482 C0397484 C0397486 C0397487 C0397488 C0397489 C0397491 C0397492 C0397493 C0397494 C0397495 C0397496 C0397497 C0397498 C0397500 C0397501 C0397502 C0400024 C0400033 C0400034 C0400035 C0400036 C0400037 C0400038 C0400039 C0400040 C0400041 C0400218 C0400219 C0400221 C0400223 C0400224 C0400225 C0400226 C0400230 C0400231 C0400232 C0400233 C0400236 C0400237 C0400238 C0400239 C0400240 C0400242 C0400243 C0402690 C0402700 C0402701 C0402704 C0402705 C0402708 C0402717 C0402719 C0402721 C0402723 C0402724 C0402727 C0402731 C0402734 C0406972 C0371720 C0395592 C0405074 C0405076 C0405101 C0405103 C0405108 C0405114 C0407649 C0407651 C0407653 C0407654 C0391968 C0403337 C0401434 C0401434
Quantity recalled160 units

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-1588-2012
FDA event ID
62443
Classification
Class II
Status
Terminated
Recall initiated
21 May 2012
FDA classified
10 Aug 2012
Reported
22 Aug 2012
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

21 May 2012Recall initiated by company
10 Aug 2012Classified by FDA+81 days
22 Aug 2012Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE 1 ML 5 ML 6 ML; NANDROLONE DECANOATE 100MG/ML INJECTABLE 5 ML; NANDROLONE DECANOATE 300MG/ML INJECTABLE 10 ML 30 ML (6 DIFFERENT PRODUCTS)

Where it was distributed

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Which lots are affected?

Rx #'s: C0371167 C0371185 C0371187 C0371193 C0381331 C0381336 C0381348 C0381353 C0381360 C0381364 C0381366 C0381371 C0384632 C0384634 C0384637 C0389199 C0389200 C0389201 C0389205 C0389216 C0389219 C0389223 C0389224 C0392398 C0392399 C0392401 C0392405 C0392407 C0392409 C0392410 C0392411 C0392412 C0392414 C0392418 C0392419 C0392421 C0392426 C0392429 C0392433 C0392434 C0392435 C0392436 C0392438 C0392441 C0394169 C0394170 C0394171 C0394172 C0394173 C0394174 C0394175 C0394176 C0394177 C0394178 C0394179 C0394180 C0396357 C0396362 C0396365 C0396370 C0396374 C0396377 C0396388 C0396397 C0396398 C0397477 C0397478 C0397479 C0397481 C0397482 C0397484 C0397486 C0397487 C0397488 C0397489 C0397491 C0397492 C0397493 C0397494 C0397495 C0397496 C0397497 C0397498 C0397500 C0397501 C0397502 C0400024 C0400033 C0400034 C0400035 C0400036 C0400037 C0400038 C0400039 C0400040 C0400041 C0400218 C0400219 C0400221 C0400223 C0400224 C0400225 C0400226 C0400230 C0400231 C0400232 C0400233 C0400236 C0400237 C0400238 C0400239 C0400240 C0400242 C0400243 C0402690 C0402700 C0402701 C0402704 C0402705 C0402708 C0402717 C0402719 C0402721 C0402723 C0402724 C0402727 C0402731 C0402734 C0406972 C0371720 C0395592 C0405074 C0405076 C0405101 C0405103 C0405108 C0405114 C0407649 C0407651 C0407653 C0407654 C0391968 C0403337 C0401434 C0401434

Where was it sold?

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

97 other products · FDA event 62443

This product is part of a recall event; the main page for the event is Tobramycin 1.4% (14mg/ML) Ophthalmic recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IITobramycin 1.4% (14mg/ML) Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILissamine Green Solution 1% Ophthalmic (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine HCL (sterile) 4% Jelly recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMannitol 20% Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITestosterone Cyp/estradiol Cyp 50mg/2mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIStrontium 1 MG/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITriamcinolone Acetonide 4mg/ML recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMolybdenum 250mcg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IINadh-ffc 10 MG/cc Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPapaverine HCL ** Vial) 30mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIIopamidol 41% Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethylcobalamin 1,000mcg/ML Injectable 26 Mls 30 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITrocar Kit, Sterile Disposable** Device 1 Kit 1 Pellet recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPovidone-iodine Ophthalmic 5% Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine/sodium Bicarbonate/heparin Irrigation recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIIsosulfan Blue 1% Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIProcaine HCL, P.f. 1% Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMagnesium Chloride, Preservative Free 20% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPapaverine/phentolamine/atropine Ns 3.6mg/0.4mg/0.04mg recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMitomycin 1mg/ML Solution recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPapaverine/alprostadil 30mg/10mcg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIOndansetron HCL, Mdv 2mg/ML (40mg/ Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIUltra-test 200 (cyp 80%/prop 20%) 200mg/ML Injectable 10 Mls 20 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethionine/inositol/choline Chloride/chrom/b12 recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IISodium Bicarbonate 4% Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVoriconazole Ophthalmic 1% (10mg/ML) Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVerapamil HCL 10mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILorazepam 2mg/ML Injectable (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITetracaine HCL Ophthalmic 0.05% Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhenylephrine/tropicamide (p.f.) Solution 2.5%/1% recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITrypan Blue Solution, P.f. 0.04% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethylcobalamin/folic Acid - Kit 10mg/0.4mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITetracosactide Acetate (cosyntropin) 0.25mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIInsulin, Lo-dose (from Humalog)/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIRiboflavin Solution 0.1% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILevothyroxine Sodium 325mcg/ML (0.325mg/ML) Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMitomycin/bupivacaine With Epi 1:200 recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITaurine 50mg/ML Injectable (4 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIL-arginine 500mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVancomycin (intraocular) Ophthalmic, P.f. (bss) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPyridoxine 100mg/ML Injectable (5 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIIohexol 200mg Iodine/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhenyleph/diclof/tropic/proparac/povidone Iodine Sol recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPenicillin G Potassium 10,000u/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITwinject*** 0.3 MG Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVancomycin/dexamethasone, Lyophilized 1%/0.1% Kit 2 Kit recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMitomycin/lidocaine/epinephrine 0.04%/0.02%/0.1% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVanadyl Sulfate Solution 200mcg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMoxifloxacin 150mcg/ (1.5mg/ML) Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMidazolam 1mg/ML Vial) Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIWater Bact Sterile - (25x30ml)*** Injectable 750 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIVitamin K (phytonadione) 10mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhentolamine 10mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILeucovorin, Lyophilized 100 MG Vial Injectable 1 Vial recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhenylephrine/tropicamide/proparacaine Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMepivacaine HCL/epinephrine recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIL-tryptophan 15mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMetoclopramide HCL 5mg/ML (10mg/ Injectable (9 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILithium Chloride 5mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IISesame Ophthalmic Oil (1 Product) recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMeyers Cocktail Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIKenalog-40** (mdv Vial) 40mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITropicamide Ophthalmic P.f. 1% Solution (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IISelenium 200mcg/ML Injectable (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIKetorolac Tromethamine 30mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILabetalol Hydrochloride 5mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine HCL/epinephrine In Bss - P.f. recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMic - Combo With Methylcobalamin 0.8/1.6/1.6/0.0001/0.03% recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITropicamide/phenylephrine Ophthalmic 15:1 Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPilocarpine HCL P.f In B.s.s Ophthalmic 1% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPhenylephrine HCL In Bss - P.f. Ophthalmic 1% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPotassium Chloride *** Vial) 2meq/ML Injectable 750 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IISermorelin Acetate, Lyophilized 6mg Kit 1 Kit 2 Kit recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine/tetracaine Ophthalmic 4%/0.5% Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITrimix 9mg / 0.3mg /3.3mcg Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPrednisolone Acetate 10mg/ML Injectable 10 Mls (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIThiotepa, Lyophilized 15mg Injectable 8 Vial recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPaclitaxel 6mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIQuadmix 12mg/1mg/10mcg/150mcg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIZinc Chloride 10mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITheracys, (bcg Vaccine) Live W/diluent** 81mg Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMorphine Sulfate 2mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIProgesterone Aqueous 2mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILevofloxacin, P.f. (premixed Solution) 5mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIRubidium 200mcg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethionine / Inositol / Choline Chloride 25mg/75mg/75mg/ML recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPantothenic Acid 1mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIRanitidine 25mg/ML Injectable (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIPovidone-iodine/lidocaine/tetracaine 4.6%/4%/0.5% recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIRanibizumab, Sdpf - Syringe, 5/16") 10mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IITrimix/lidocaine 11.8mg/0.39mg/10.6mcg/1.7mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine HCL/bupivacaine HCL Pf 1%/0.375% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIThiamine HCL 100mg/ML Injectable (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIOxytocin/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethylprednisolone Acetate 100mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IILidocaine/epinephrine/bupivacaine, Pf 1%/0.00025%/0.375% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIMethylprednisolone Acetate/lidocaine HCL 40mg/10mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide

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