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

Fentanyl, P.f. 100mcg/ML Injectable recalled

Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Fentanyl, P.f. 100mcg/ML Injectable, distributed nationwide in the US. The recall was initiated on 25 May 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesRx #'s:N0395099 N0389078 N0389083 N0389084 N0389085 N0389086 N0389089 N0389090 N0389093 N0389095 N0389097 N0389099 N0389100 N0390325 N0390326 N0390328 N0390329 N0390331 N0390332 N0390333 N0390338 N0390377 N0390380 N0390382 N0390383 N0390385 N0390390 N0390393 N0392339 N0392343 N0392344 N0392345 N0392347 N0392349 N0392351 N0392353 N0392354 N0392355 N0392357 N0392360 N0392363 N0392364 N0392367 N0392368 N0392370 N0392372 N0392374 N0392375 N0397646 N0397796 N0397797 N0397798 N0397802 N0397803 N0397804 N0397805 N0397806 N0397807 N0397990 N0397993 N0397994 N0397996 N0397997 N0398016 N0398017 N0398019 N0398020 N0398021 N0396955 N0398306 N0405187 N0401002 N0396784 N0398527 N0400271 N0400917 N0407735 N0409318 N0398310 N0408255 N0399153 N0404847 N0398297 N0399447 N0403452 N0406065 N0409741 N0397353 N0398612 N0406345 N0408105 N0393498 N0395106 N0401234 N0402072 N0402652 N0406677 N0397637 N0400888 N0398823 N0399918 N0400676 N0404455 N0398592 N0409187 N0393520 N0394243 N0406426 N0407548 N0397583
Quantity recalled110 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-1518-2012
FDA event ID
62416
Classification
Class II
Status
Terminated
Recall initiated
25 May 2012
FDA classified
10 Aug 2012
Reported
22 Aug 2012
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility
Drug class
Pain Medication

Timeline

25 May 2012Recall initiated by company
10 Aug 2012Classified by FDA+77 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 because 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

FENTANYL, P.F. 100MCG/ML INJECTABLE 12 ML, 2 ML, 30 ML, 60 ML; FENTANYL, P.F. 50MCG/ML (100MCG/2ML) INJECTABLE 100 ML, 120 ML, 150 ML, 20 ML, 200 ML, 24 ML, 250 ML, 30 ML, 300 ML, 40 ML, 400 ML, 50 ML, 60 ML; FENTANYL, WITH PRESERVATIVES 50MCG/ML INJECTABLE 30 ML (18 DIFFERENT PRODUCTS)

Where it was distributed

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and 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 because 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:N0395099 N0389078 N0389083 N0389084 N0389085 N0389086 N0389089 N0389090 N0389093 N0389095 N0389097 N0389099 N0389100 N0390325 N0390326 N0390328 N0390329 N0390331 N0390332 N0390333 N0390338 N0390377 N0390380 N0390382 N0390383 N0390385 N0390390 N0390393 N0392339 N0392343 N0392344 N0392345 N0392347 N0392349 N0392351 N0392353 N0392354 N0392355 N0392357 N0392360 N0392363 N0392364 N0392367 N0392368 N0392370 N0392372 N0392374 N0392375 N0397646 N0397796 N0397797 N0397798 N0397802 N0397803 N0397804 N0397805 N0397806 N0397807 N0397990 N0397993 N0397994 N0397996 N0397997 N0398016 N0398017 N0398019 N0398020 N0398021 N0396955 N0398306 N0405187 N0401002 N0396784 N0398527 N0400271 N0400917 N0407735 N0409318 N0398310 N0408255 N0399153 N0404847 N0398297 N0399447 N0403452 N0406065 N0409741 N0397353 N0398612 N0406345 N0408105 N0393498 N0395106 N0401234 N0402072 N0402652 N0406677 N0397637 N0400888 N0398823 N0399918 N0400676 N0404455 N0398592 N0409187 N0393520 N0394243 N0406426 N0407548 N0397583

Where was it sold?

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

99 other products · FDA event 62416

This product is part of a recall event; the main page for the event is Alprostadil 10mcg/ML Injectable recalled by Franck's Lab Inc., d.b.a..

ReportedClassRecallCompanyReasonWhere
CLASS IIAlprostadil 10mcg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAflibercept, Sdpf - Syringe, 5/16") 40mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICyclopent/phenyleph/tropicamide/proparacaine recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIEpinephrine **(25x1ml Ampuls) 1:1000 1mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIEngerix-b, Sdv** 20mcg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAtropine Sulfate 0.4mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIForskolin/phentolamine 200mcg / 2mg Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICeftazidime Ophthalmic, P.f. 22.5mg/ML (2.25%) Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDroptainer Sterile Plastic (2 X (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHydroxocobalamin**(vit B-12) 1000mcg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAcyclovir Ophthalmic 3% Ointment 5 Gm recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHyaluronidase / Lidocaine 7.1u/9.5mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHydromorphone/clonidine P. F. 120mg/1.3mcg/ML Intrathecal recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICyclosporine (a) Aqueous (human) 0.5% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDexamethasone/bacteriostatic Water Iontophoresis recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDmso/heparin/methylprednisolone 50%/5000u/40mg/ Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIG-c-p 0.1%/0.1%/0.05% Solution, 250 Mls (3 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIChromium Picolinate 200mcg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHydroxyprogesterone Caproate 250mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHydromorphone P.f. 20mg/ML Intrathecal recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHyaluronidase - Preservative Free 150 U/ML Injectable 1 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAcetylcysteine, Ophthalmic In Artificial Tears 10% Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine/sufentanil, P.f. 15mg/150mcg/ML Intrathecal (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBrilliant Blue G, P.f. 0.025% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBiest(80/20) 6.25mg/gm (1.25mg/ I-cream (5 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine/clonidine/hydromorphone recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICyclopent/flurbipr/phenyleph/proparacaine recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIIndocyanine Green - Kit 15mg Injectable 1 Kit, 100 Kit recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIGlutathione Inhalation 30mg/ML Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine/lidocaine/methylprednisolone 0.17% recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICyclopentalate/phenylephrine 1%/2.5% Ophthalmic (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine/clonidine/morphine/ziconotide recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIFluorescein/indocyanine, Lyophilized 200mg/10mg Vial recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICyclopent/ketorolac/phenyleph/tropicamide 1%/0.5%/2.5%/1% recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICisplatin 1mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine HCL & Epinephrine, P.f. 0.25% / 1:200,000 Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine/fentanyl In Sodium Chloride 0.9% P. F. recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBaclofen/morphine, P.f. 1,000mcg/25mg/ML Intrathecal recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDiclofenac Sodium, Sdpf - Syringe, 1/2") 500mcg/ Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICopper Gluconate 2mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIForskolin/papavarine/phentolamine 200mcg/40mg/3mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBaclofen/hydromorphone, P.f. 2000mcg/2.9mg/ML Intrathecal recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAcetic Acid, Irrigation 3% Solution (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBacteriostatic Sodium Chloride Vial** 0.9% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHyaluronic Acid Sodium Salt 10mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine/morphine Sulfate, P.f. 2.5mg/10mg/ML Intrathecal recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAmphotericin B Ophthalmic, Ll Syringe) P.f. 10mcg/ Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBimix 30mg / 4mg Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDexamethasone Sodium Phosphate Pf 0.04% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAmikacin P. F. 250mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine/lidocaine 0.11% / 0.44% Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHyaluronidase / Lidocaine / Bupicavaine 7.1u/9.5mg/3.5mg/ML recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIFormix 100mcg / 30mg / 1mg Injectable, 10 Mls recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICefazolin In Artificial Tears 50mg/ML Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine/hydromorphone, P.f. 15mg/40mg/ML Intrathecal recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAminophylline, Sdv** 500mg (25mg/ML) Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHydromorphone/baclofen/bupivacaine recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIEdetate Disodium Pf In Bss 3% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIGentamicin 40mg/ML (80mg/ Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIGlycerin 99.5% Ophthalmic recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIEtomidate 0.2% (2mg/ML) Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDiazepam (im/iv) 1mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIGancyclovir, Sdpf -, 1/2" Syringe) 20mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIEthyl Alcohol 10% Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAscorbic Acid (beet Source) 500mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIClindamycin Ophthalmic (pf) 20mg/ML (2mg/ Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDiphenhydramine 25mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIEdta Disodium Solution 33.6mg/ML (0.1 Molar) Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHyaluronidase/methylprednisolone Acetate recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDapiprazole Ophthalmic 0.5% Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDextrose/procaine HCL P.f. 12%/1% Injectable ( 1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIFurosemide*** (25x10ml) 10mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBevacizumab & Dxm, Sdpf - Syringe, 5/16") 25mg/100mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHypertonic Solution In Preserved Water 10% Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIFluorouracil (5-fu) Solution 5% Ophthalmic recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDmso/heparin 50%/20,000u/ Solution recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDoxorubicin HCL, Lyophilized 10mg Vial 2 Vial recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBupivacaine/clonidine/morphine recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDmps 250mg/ Injectable recalled by Franck's Lab Inc., d.b.a.Franck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBaclofen, P.f. (with 0.9% P.f. Normal Saline) 2,000mcg/ML recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAlteplase, Sdpf - Syringe, 1/2") 1000mcg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBaclofen/bupivacaine/clonidine/morphine recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICyclopent/lidocaine/phenylephrine/tropicamide recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBoron 2mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIEstradiol 25mg Pellets 1 Pellet, 15 Pel, 15 Pellet recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDmso/vitamin C/glutathione Solution 6.25%/1.25%/1.25% recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIBudesonide (p.f) Nasal Irrigation 0.5mg/ Solution recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICyanocobalamin (vit B12 ) 1,000mcg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHydrogen Peroxide Pf 3% Injectable (4 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHydrochloric Acid Injection 2mg/ML Injectable (2 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDexpanthenol 250mg/ML Injectable (4 Different Products) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDepo-testosterone, Mdv** 200mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IICalcium Chloride Dihydrate, P.f. 100mg/ML (10%) Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHeparin Lock Sodium*** (25x1ml) 100u/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIHumulin-r Insulin Vial** 100u/ML Injectable 10 Mls (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIDmso / Bupivacaine HCL 50%/0.5% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIChorionic Gonadotropin (standard) - 21 Day Vials Kit 1 Kit recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIAcetazolamide, Lyophilized 500mg Injectable10 Vial, 4 Vial recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
CLASS IIFolic Acid 10mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide

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