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
G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)
Drugs·6 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CHROMIUM PICOLINATE 200MCG/ML INJECTABLE 60 ML (1 PRODUCT)
Injectable Drugs·4 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML, 12 ML, 13 ML, 15 ML, 3 ML, 30 ML, 4 ML, 5 ML, 6 ML, 7 ML, 9 ML (11 DIFFERENT PROD...
Injectable Drugs·48 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
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, 2...
Injectable Drugs·110 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 30MG/ML INTRATHECAL 18 ML...
Drugs·8 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYALURONIDASE - PRESERVATIVE FREE 150 U/ML INJECTABLE 1 MLS, 10 MLS, 100 MLS, 12 MLS, 12.5 ML, 120 MLS, 15 MLS, 16 ML, 16 MLS, 2 MLS, 20 ...
Injectable Drugs·326 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 10% SOLUTION 10 ML, 2 ML, 5 ML, 6 ML; ACETYLCYSTEINE, OPHTHALMIC IN ARTIFICIAL TEARS 2.5% ...
Ophthalmic Drugs·16 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/SUFENTANIL, P.F. 15MG/150MCG/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
BRILLIANT BLUE G, P.F. 0.025% OPHTHALMIC 10 ML, 20 ML, 26 ML, 4 ML; BRILLIANT BLUE G, P.F. (0.5ML SYRINGE) 0.25MG/ML OPHTHALMIC 2 ML, 2...
Ophthalmic Drugs·107 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS)
Topical Drugs·7 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML ...
Drugs·5 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFERENT PRODUCTS)
Ophthalmic Drugs·6 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECT...
Injectable Drugs·134 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 M...
Injectable Drugs·47 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/LIDOCAINE/METHYLPREDNISOLONE 0.17% / 0.67% / 2.7% INJECTABLE 15 ML, 18.75 ML, 26.25 ML, 37.5 ML, 45 ML; BUPIVACAINE/LIDOCAINE...
Injectable Drugs·7 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT)
Ophthalmic Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/CLONIDINE/MORPHINE/ZICONOTIDE, P.F. 20MG/400MCG/20MG/1.5MCG/ML INTRA 20 ML (1 PRODUCT)
Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15M...
Injectable Drugs·202 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CYCLOPENT/KETOROLAC/PHENYLEPH/TROPICAMIDE 1%/0.5%/2.5%/1% OPHTHALMIC 70 ML (1 PRODUCT)
Ophthalmic Drugs·3 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·3 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% / 1:200,000 INJECTABLE ...
Injectable Drugs·79 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT)
Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPH...
Drugs·3 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DICLOFENAC SODIUM, SDPF - (0.1ML SYRINGE, 30G, 1/2") 500MCG/0.1ML INJECTABLE 0.5 ML, 2 ML, 4 ML (3 DIFFERENT PRODUCTS)
Injectable Drugs·5 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS)
Injectable Drugs·3 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG...
Injectable Drugs·4 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/...
Drugs·6 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ACETIC ACID, IRRIGATION 3% SOLUTION 500 ML (1 PRODUCT)
Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20 MLS, 200 ML, 30 MLS, 40 ML, 50 ML, 50 MLS (10 D...
Injectable Drugs·27 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MG/ML INJECTABLE 500 ML (3 DIFFERENT P...
Injectable Drugs·3 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/MORPHINE SULFATE, P.F. 2.5MG/10MG/ML INTRATHECAL 40 ML; BUPIVACAINE/MORPHINE SULFATE, P.F. 7.5MG/25MG/ML INTRATHECAL 20 ML; B...
Drugs·16 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
AMPHOTERICIN B OPHTHALMIC (0.5ML, LL SYRINGE) P.F. 10MCG/0.1ML INJECTABLE 1 ML, 1.5 ML, 2 ML, 2.5 ML, 5 ML; AMPHOTERICIN B OPHTHALMIC 5MC...
Injectable Drugs·15 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG ...
Injectable Drugs·448 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DEXAMETHASONE SODIUM PHOSPHATE PF 0.04% OPHTHALMIC 2 ML; DEXAMETHASONE / LIDOCAINE 0.5%/3% INJECTABLE 30 MLS; DEXAMETHASONE ACETATE (...
Injectable Drugs·73 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
AMIKACIN P. F. 250MG/ML INJECTABLE 2 ML,4 ML; AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML; AMIKACIN SULFATE, LYOPHILIZED 4MG ...
Injectable Drugs·42 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/LIDOCAINE 0.11% / 0.44% INJECTABLE 150 ML (1 PRODUCT)
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYALURONIDASE / LIDOCAINE / BUPICAVAINE 7.1U/9.5MG/3.5MG/ML INJECTABLE 210 ML, 525 ML, 630 ML; HYALURONIDASE/LIDOCAINE/EPI/BUPIVICAINE I...
Injectable Drugs·9 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
FORMIX 100MCG / 30MG / 1MG INJECTABLE 10 ML, 10 MLS, 5 ML; FORMIX 100MCG / 30MG / 2MG INJECTABLE 10 ML (4 DIFFERENT PRODUCTS)
Injectable Drugs·12 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS)
Injectable Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
BUPIVACAINE/HYDROMORPHONE, P.F. 15MG/40MG/ML INTRATHECAL 40 ML; BUPIVACAINE/HYDROMORPHONE, P.F. 22MG/30MG/ML INTRATHECAL 40 ML; BUPIVACAI...
Drugs·15 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT)
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50...
Drugs·7 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
EDETATE DISODIUM PF IN BSS 3% OPHTHALMIC 10 ML; EDETATE DISODIUM SOLUTION IN ARTIFICIAL TEARS 0.05% OPHTHALMIC 10 ML (2 DIFFERENT PRODUCTS)
Ophthalmic Drugs·2 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
GENTAMICIN 40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML; GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 100...
Injectable Drugs·171 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)
Ophthalmic Drugs·4 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT)
Injectable Drugs·1 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
DIAZEPAM (IM/IV) 1MG/ML INJECTABLE 40 ML, 60 ML; DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 2 ML, 20 ML, 300 ML; DIAZEPAM 2.5MG/ML INJECTABLE 40 ...
Injectable Drugs·13 affected·May 25, 2012
High RiskFDA
Franck's Lab Inc., D.b.a. Franck's Compounding Lab
GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)
Injectable Drugs·1 affected·May 25, 2012