Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ETHYL ALCOHOL 10% INJECTABLE 30 ML; ETHYL ALCOHOL 100%INJECTABLE 10 ML, 100 ML, 20 ML, 40 ML, 5 ML, 60 ML; ETHYL ALCOHOL 20% INJECTABLE 5...
Injectable Drugs·17 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ASCORBIC ACID (BEET SOURCE) 500MG/ML INJECTABLE 100 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 60 ML; ASCORBIC ACID (CORN SOURCE...
Injectable Drugs·19 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CLINDAMYCIN OPHTHALMIC (PF) 20MG/ML (2MG/0.1ML) SOLUTION 2 ML; CLINDAMYCIN PHOSPHATE OPHTHALMIC, INTRAVITREAL (P.F.) 1MG/0.1ML INJECTABL...
Injectable Drugs·5 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DIPHENHYDRAMINE 25MG/ML INJECTABLE 90 ML; DIPHENHYDRAMINE 50MG/ML INJECTABLE 10 ML, 100 ML, 108 ML, 120 MLS, 25 ML, 32 ML, 60 ML, 90 ML,...
Injectable Drugs·26 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
EDTA DISODIUM SOLUTION 33.6MG/ML (0.1 MOLAR) OPHTHALMIC 15 ML; EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 100 ML, 24...
Injectable Drugs·28 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT)
Injectable Drugs·4 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DAPIPRAZOLE OPHTHALMIC 0.5% SOLUTION 10 ML; DAPIPRAZOLE, LYOPHILIZED, OPHTHALMIC KIT 0.5% POWDER 1 KIT, 10 KIT, 2 KIT, 3 KIT, 4 KIT, 6 KI...
Ophthalmic Drugs·25 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DEXTROSE/PROCAINE HCL P.F. 12%/1% INJECTABLE 400 ML ( 1 PRODUCT)
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FUROSEMIDE*** (25X10ML) 10MG/ML INJECTABLE 250 ML; FUROSEMIDE*** (25X4ML) 10MG/ML INJECTABLE 2 VIAL (2 DIFFERENT PRODUCTS)
Injectable Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, 5/16") 25MG/100MG/ML INJECTABLE 0.72 ML; BEVACIZUMAB & DXM, SDPF - (0.06ML SYRINGE, 31G, ...
Injectable Drugs·2,350 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYPERTONIC SOLUTION IN PRESERVED WATER 10% INJECTABLE 50 ML (1 PRODUCT)
Injectable Drugs·3 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FLUOROURACIL (5-FU) SOLUTION 5% OPHTHALMIC 100 ML; FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL ...
Injectable Drugs·14 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMSO/HEPARIN 50%/20,000U/25ML SOLUTION 100 ML, 25 ML; DMSO/HEPARIN 50%/5000U/50ML SOLUTION 300 ML, 400 ML (4 DIFFERENT PRODUCTS)
Drugs·8 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 2 VIAL; DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1 VIAL, 10 VIAL, 5 VIAL (4 DIFFERENT PRODUCTS)
Drugs·4 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 20MG/400MCG/20MG/ML INTRATHECAL 20 ML (1 PRODUCT)
Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMPS 250MG/10ML INJECTABLE 20 ML, 30 ML; DMPS 50MG/ML (500MG/10ML) INJECTABLE 10 ML, 5 ML (4 DIFFERENT PRODUCTS)
Injectable Drugs·6 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 2,000MCG/ML (2MG/ML) INTRATHECAL 40 ML; BACLOFEN, P.F. (WITH 0.9% P.F. NORMAL SALINE) 600MC...
Injectable Drugs·21 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ALTEPLASE, SDPF - (0.05ML SYRINGE, 30G, 1/2") 1000MCG/ML INJECTABLE 0.05 ML; ALTEPLASE, SDPF - (0.15ML LL SYRINGE, NO NEEDLE) 100MCG/ML (...
Injectable Drugs·16 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50M...
Drugs·10 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYCLOPENT/LIDOCAINE/PHENYLEPHRINE/TROPICAMIDE 0.5%/0.5%/0.625%/0.25% OPHTHALMIC 20 ML (1 PRODUCT)
Ophthalmic Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BORON 2MG/ML INJECTABLE 40 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ESTRADIOL 25MG PELLETS 1 PELLET, 15 PEL, 15 PELLET, 2 PELLET, 2 TAB, 3 PELLET, 4 PELLET, 6 PELL, 6 PELLET; ESTRADIOL 50MG PELLETS 1 PELEL...
Injectable Drugs·72 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMSO/VITAMIN C/GLUTATHIONE SOLUTION 6.25%/1.25%/1.25% OPHTHALMIC 10 ML, 15 ML, 5 ML (3 DIFFERENT PRODUCTS)
Supplements·9 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML SOLUTION 1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML SOLUTION 1500 ML (2 DIFFER...
Inhaled / Nasal Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYANOCOBALAMIN (VIT B12 ) 1,000MCG/ML INJECTABLE 1 ML, 10 ML, 100 ML, 12 ML, 120 ML, 15 ML, 150 ML, 180 ML, 2 ML, 200 ML, 3 ML, 30 ML, 30...
Injectable Drugs·86 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROGEN PEROXIDE PF 3% INJECTABLE 150 ML, 200 ML, 50 ML, 60 ML (4 DIFFERENT PRODUCTS)
Injectable Drugs·8 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROCHLORIC ACID INJECTION 2MG/ML INJECTABLE 400 ML, 60 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·6 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DEXPANTHENOL 250MG/ML INJECTABLE 100 ML, 120 ML, 360 ML, 450 ML (4 DIFFERENT PRODUCTS)
Injectable Drugs·5 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML (1 PRODUCT)
Injectable Drugs·9 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIUM EDTA 150MG/ML INJECTABLE 1000 ML, 800 ML, 900 ...
Injectable Drugs·21 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS; HEPARIN SODIUM (25...
Injectable Drugs·12 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HUMULIN-R INSULIN, 10ML VIAL** 100U/ML INJECTABLE 10 MLS (1 PRODUCT)
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION ...
Injectable Drugs·107 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT;...
Injectable Drugs·193 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS)
Injectable Drugs·10 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FOLIC ACID 10MG/ML INJECTABLE 60 ML (1 PRODUCT)
Injectable Drugs·2 affected·May 25, 2012
High RiskFDA
Ekos Corporation
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-...
Surgical Devices·21,892 affected·May 24, 2012
High RiskFDA
Stingray Surgical Products, Llc
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Han...
Surgical Devices·6,326 affected·May 23, 2012
High RiskFDA
Synthes Usa Hq, Inc.
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101...
Medical Devices·20 affected·May 22, 2012
High RiskFDA
Synthes Usa Hq, Inc.
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101...
Medical Devices·20 affected·May 22, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
TOBRAMYCIN 1.4% (14MG/ML) OPHTHALMIC 15 ML 3 ML 7 ML; TOBRAMYCIN SOLUTION** 0.3% OPHTHALMIC 30 MLS 5 MLS; TOBRAMYCIN ...
Injectable Drugs·13 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
LISSAMINE GREEN SOLUTION 1% OPHTHALMIC 10 ML (1 PRODUCT)
Ophthalmic Drugs·1 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
LIDOCAINE HCL (STERILE) 4% JELLY 120 ML 30 ML; LIDOCAINE HCL 4% SOLUTION 200 ML 300 ML 500 ML 600 ML; ...
Injectable Drugs·434 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
MANNITOL 20% INJECTABLE 1250 ML 250 ML 2500 ML 400 ML; MANNITOL 25% INJECTABLE 1200 ML 300 ML 350 ML ...
Injectable Drugs·17 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
TESTOSTERONE CYP/ESTRADIOL CYP 50MG/2MG/ML INJECTABLE 5 ML; TESTOSTERONE CYPIONATE 50MG/ML INJECTABLE 12 ML 2.5 ML (4 DIFFERENT PRODU...
Injectable Drugs·17 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
STRONTIUM 1 MG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·4 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T), STSL (0.025ML SYRINGE, 30G, 1/2") 40M...
Injectable Drugs·87 affected·May 21, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
MOLYBDENUM 250MCG/ML INJECTABLE 30 ML 60 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·6 affected·May 21, 2012