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

Hyaluronidase/methylprednisolone Acetate recalled

Franck's Lab Inc., d.b.a. Franck's Compounding Lab is recalling Hyaluronidase/methylprednisolone Acetate, P.f. 37.5u/20mg/ML Injectable (1 Product), 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 #: 0383354
Quantity recalled4 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-1537-2012
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

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

HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT)

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 #: 0383354

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 IIFentanyl, P.f. 100mcg/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 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

More recalls from Franck's Lab Inc., d.b.a. Franck's Compounding Lab

All 198
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIMethylprednisolone Acetate/lidocaine HCL 40mg/10mg/ML Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
DrugCLASS IIFolic Acid 10mg/ML Injectable (1 Product) recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
DrugCLASS IIAcetazolamide, Lyophilized 500mg Injectable10 Vial, 4 Vial recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
DrugCLASS IIChorionic Gonadotropin (standard) - 21 Day Vials Kit 1 Kit recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide
DrugCLASS IIDmso / Bupivacaine HCL 50%/0.5% Injectable recalledFranck's Lab Inc., d.b.a. Franck's Compounding LabSterilityNationwide

Other Hyaluronidase recalls

All 9
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIHylenex recombinant (hyaluronidase) injection recalledHylenex RecombinantMckesson Medical-Surgical Inc. Corporate OfficeManufacturing (CGMP) DeviationsVA
DrugCLASS IIHyaluronidase/ml Injection, ml, Sterile, Preserved recalledThe Compounding Pharmacy of AmericaSterilityNationwide
DrugCLASS IIHyaluronidase/ml Injection, ml, Sterile, Preservative Free recalledThe Compounding Pharmacy of AmericaSterilityNationwide
DrugCLASS IIHyaluronidase/ml Injection, ml, Sterile, Preserved recalledThe Compounding Pharmacy of AmericaSterilityNationwide
DrugCLASS IIHyaluronidase, 240 u/mL, injectable glass vial, RX recalledOregon Compounding CentersSterilityOR, WA