FDA (Drugs) recall action 62416

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled 100 products on 2012-08-22

The FDA (Drugs) publishes a recall like this one as 100 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 100 pages.

Products: 100
Announced: 2012-08-22
Critical: 0
Units: 5,995

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

51–75 of 100

SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Intrathecal Drug Mixtures Due to Contamination
Franck's Lab Inc. is recalling sterile intrathecal drug mixtures because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 20MG/400MCG/2MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 7.5MG/1.5MCG/50MG/ML INTRATHECAL; BUPIVACAINE/CLONIDINE/HYDROMORPHONE, P.F. 5MG/500MCG/50MG/ML INTRATHECAL (4 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Fluorescein/Indocyanine Drugs Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile Fluorescein/Indocyanine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 1
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Recall of Sterile Hyaluronic Acid Sodium Salt Injectable Drugs
Franck's Lab Inc. is recalling sterile hyaluronic acid sodium salt injectable drugs due to the presence of microorganisms and fungal growth in the clean room.
Product
HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MG/ML INJECTABLE 500 ML (3 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Intrathecal Baclofen and Hydromorphone Mixtures
Franck's Lab Inc. is recalling sterile intrathecal drug mixtures due to microorganisms and fungal growth found in the clean room.
Product
BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/2.9MG/ML INTRATHECAL 20 ML; BACLOFEN/HYDROMORPHONE, P.F. 2000MCG/6MG/ML INTRATHECAL 40 ML; BACLOFEN/HYDROMORPHONE, P.F. 500MCG/50MG/ML INTRATHECAL 40 ML (2 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Aminophylline Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Aminophylline injectable products because FDA testing found microorganisms in the clean room where they were prepared.
Product
AMINOPHYLLINE 20ML, SDV** 500MG (25MG/ML) INJECTABLE 20 ML (1 PRODUCT)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Cefazolin Sterile Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile Cefazolin drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Product
CEFAZOLIN IN ARTIFICIAL TEARS 50MG/ML OPHTHALMIC 10 ML; CEFAZOLIN VIAL*(25X1GM) 1GM INJECTABLE 10 VIAL (2 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Glycerin Ophthalmic Products Due to Sterility Concerns
Franck's Lab Inc. is recalling four glycerin ophthalmic products because FDA testing found microorganisms and fungal growth in the facility's clean room.
Product
GLYCERIN 99.5% OPHTHALMIC 10 ML, 5 ML, 7.5 ML; GLYCERIN 100% OPHTHALMIC 15 ML (4 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Etomidate Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Etomidate 0.2% Injectable because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.
Product
ETOMIDATE 0.2% (2MG/ML) INJECTABLE 20 ML (1 PRODUCT)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile hyaluronidase/methylprednisolone acetate injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.
Product
HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Heparin Sodium Injectable Recall Due to Sterility Assurance Failure
Franck's Lab Inc. is recalling heparin sodium injectables because FDA sampling found microorganisms and fungal growth in the clean room where sterile products were prepared.
Product
HEPARIN LOCK SODIUM*** (25X1ML) 100U/ML INJECTABLE 50 ML; HEPARIN LOCK SODIUM*** (25X5ML) 100U/ML INJECTABLE 125 MLS; HEPARIN SODIUM (25X30ML)** 1000U/ML(1MU/ML) INJECTABLE 120 ML, 60 ML, 90 ML; HEPARIN SODIUM **25X1ML 1000U/ML(1MU/ML INJECTABLE 25 ML, 50 ML (7 DIFFERENT PRODUCT
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile human drugs, including Chorionic Gonadotropin, because FDA sampling found microorganisms in the clean room.
Product
CHORIONIC GONADOTROPIN (STANDARD) - 21 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD) - 45 DAY 200 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-21 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONIC GONADOTROPIN (STANDARD)-45 DAY 125 UNIT VIALS KIT 1 KIT; CHORIONI
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML (1 PRODUCT)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Epinephrine Products Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile epinephrine products distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the clean room.
Product
EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HCL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML; EPIINEPHRINE P.F. (SULFITE-FREE) 1:1,000 (1MG/ML) INJECTABLE 1 ML, 2 ML, 20 ML, 25 ML, 3 ML, 30 ML, 4 ML, 5 ML, 50 ML; EPINEPHRINE PF IN BSS, OPHTHALMIC (CONTAINS S
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Forskolin/Phentolamine Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Forskolin/Phentolamine injectable units because FDA sampling found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.
Product
FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the preparation clean room.
Product
DROPTAINER STERILE PLASTIC (2 X 7ML) 10 BOTTLE 4 PK (2 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Hydroxocobalamin Injections Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Hydroxocobalamin injections because FDA testing found microorganisms and fungal growth in the production clean room.
Product
HYDROXOCOBALAMIN**(VIT B-12) 1000MCG/ML INJECTABLE 30 ML Injectable (4 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Hyaluronidase Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile hyaluronidase injectables distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
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 ML, 20 MLS, 24 MLS, 25 ML, 30 ML, 30 MLS, 36 MLS, 4 MLS, 40 MLS, 44 ML, 5 MLS, 50 ML, 50 MLS, 6 ML, 6 MLS, 60 MLS, 8 MLS, 80 MLS, 9 ML; HYALUR
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Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Cyclosporine Ophthalmic Drugs Due to Sterility Concerns
Franck's Lab Inc. is recalling 40 units of cyclosporine ophthalmic drugs because FDA sampling found microorganisms in the clean room where they were prepared.
Product
CYCLOSPORINE (A) AQUEOUS (HUMAN) 0.5% OPHTHALMIC 10 ML, 5 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 0.2% OPHTHALMIC 10 ML; CYCLOSPORINE (A) AQUEOUS PF (HUMAN) 1% OPHTHALMIC 10 ML; CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 15 ML; CYCLOSPORINE (A) OIL SOLUTION 1% OPHTH
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Human Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile human drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.
Product
BIEST(80/20) 6.25MG/GM (1.25MG/0.2ML) I-CREAM 6 ML (5 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Contamination
Franck's Lab Inc. is recalling specific sterile ophthalmic drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.
Product
CYCLOPENT/FLURBIPR/PHENYLEPH/PROPARACAINE .25%/0.0075%/0.625%/0.125% OPHTHALMIC 56 ML, 70 ML (2 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms in the production clean room.
Product
CYCLOPENTALATE/PHENYLEPHRINE 1%/2.5% OPHTHALMIC 5 ML (1 PRODUCT)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Cisplatin Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Cisplatin 1mg/ml injectable products because FDA sampling found microorganisms in the clean room where they were prepared.
Product
CISPLATIN 1MG/ML INJECTABLE 1000 ML, 2000 ML (2 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Bupivacaine and Fentanyl Intrathecal Solutions
Franck's Lab Inc. is recalling sterile bupivacaine and fentanyl intrathecal solutions due to microbial contamination found in the clean room.
Product
BUPIVACAINE/FENTANYL IN SODIUM CHLORIDE 0.9% P. F. 30 MG/200 MCG/ML INTRATHECAL 40 ML (1 PRODUCT)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Copper Gluconate Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Copper Gluconate 2mg/mL Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.
Product
COPPER GLUCONATE 2MG/ML INJECTABLE 30 ML, 60 ML (2 DIFFERENT PRODUCTS)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Microbial Contamination
Franck's Lab Inc. is recalling specific sterile injectable drugs because FDA testing found microorganisms and fungal growth in the facility's clean room.
Product
FORSKOLIN/PAPAVARINE/PHENTOLAMINE 200MCG/40MG/3MG/ML INJECTABLE 5 ML; FORSKOLIN/PAPAVARINE/PHENTOLAMINE/ALPROSTADIL 100MCG/30MG/1MG/30MCG/ML INJECTABL 10 ML; (2 DIFFERENT PRODUCTS)
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Distribution
0 states