FDA (Drugs) recall action 62443

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalled 98 products on 2012-08-22

The FDA (Drugs) publishes a recall like this one as 98 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 98 pages.

Products: 98
Announced: 2012-08-22
Critical: 0
Units: 6,766

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. 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.

1–25 of 98

SevereFDA (Drugs)··2012-08-22
Franck's Compounding Lab Recalls Sterile Triamcinolone Acetonide Drugs
Franck's Compounding Lab is recalling sterile triamcinolone acetonide drugs distributed between November 2011 and May 2012 due to the presence of microorganisms and fungal growth in the clean room.
Product
TRIAMCINOLONE ACETONIDE 4MG/ML (0.4MG/0.1ML) INJECTABLE 10 ML 5 ML TRIAMCINOLONE ACETONIDE (T), STSL (0.025ML SYRINGE, 30G, 1/2") 40MG/ML (4MG/0.1M 0.075 SYR 0.1 SYR TRIAMCINOLONE ACETONIDE 0.25ML SYRINGE (T) 40MG/ML (4MG/0.1ML) OPHTHALMIC 0.25 ML 0.5 ML TRIAMC
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Methylcobalamin Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile methylcobalamin injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
METHYLCOBALAMIN 1,000MCG/ML INJECTABLE 10 ML 12 ML 15 ML 150 ML 2 ML 26 MLS 3 ML 30 ML 30 MLS
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Lidocaine/Tetracaine Ophthalmic Solution Due to Sterility Concerns
Franck's Lab Inc. is recalling Lidocaine/Tetracaine Ophthalmic Solution because FDA testing found microorganisms and fungal growth in the clean room where the sterile drugs were prepared.
Product
LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION 10 ML 15 ML 20 ML 200 ML 240 ML 300 ML 400 ML (7 DIFFERENT PRODUCTS)
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Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Compounding Lab Recalls Sterile Leucovorin Vials Due to Microbial Contamination
Franck's Compounding Lab is recalling sterile leucovorin vials because FDA environmental sampling found microorganisms and fungal growth in the clean room where the products were prepared.
Product
LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 10 VIAL 100 VIAL 2 VIAL 24 VIAL 30 VIAL 50 VIAL 60 VIAL 76 VIAL; LEUCOVORIN, LYOPHILIZED 350 MG VIAL INJECTABLE 10 VIAL 15 VIAL 20 VIAL 22 VIAL 28 VIAL 30 VIAL
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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 injectable drugs distributed between November 2011 and May 2012 after FDA sampling found microorganisms and fungal growth in the clean room.
Product
MEYERS COCKTAIL INJECTABLE 30 ML; MEYERS COCKTAIL (DR. MORENO) INJECTABLE 90 ML; MEYERS COCKTAIL/ CALCIUM/VIT B1/ METHYLCOBALAMIN 1GM/5MG/1000MCG/500ML INJECTAB 250 ML 5 ML (4 DIFFERENT PRODUCTS)
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
MITOMYCIN/BUPIVACAINE WITH EPI 1:200,000 0. 04MG/0.5% PER 0.3ML SYR INJECTABLE 3 ML (1 PRODUCT)
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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 injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
POTASSIUM CHLORIDE ***(30ML VIAL) 2MEQ/ML INJECTABLE 750 MLS; POTASSIUM CHLORIDE IN NORMAL SALINE 40MEQ/100ML (400MEQ/L) INJECTABLE 1000 ML; POTASSIUM CHLORIDE**(25X20ML) 2MEQ/ML INJECTABLE 500 ML; POTASSIUM PHOSPHATE 4.4MEQ/ML (3MMOL/ML) INJECTABLE 300 ML 750 ML (5 DIF
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Ondansetron Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling 16 units of Ondansetron HCL injectable products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 ML 48 ML 600 ML 800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE 20 ML 200 ML 24 ML 40 ML 48 ML (11 DIFFERENT PRODUCTS)
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile L-Arginine Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile L-Arginine 500mg/mL injectable products distributed between November 2011 and May 2012 because FDA testing found microorganisms and fungal growth in the clean room.
Product
L-ARGININE 500MG/ML INJECTABLE 2500 ML 500 ML (2 DIFFERENT PRODUCTS)
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile ophthalmic solutions because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
PHENYLEPH/DICLOF/TROPIC/PROPARAC/POVIDONE IODINE SOL. 10%/0.1%/1%/0.5%/5% OPHTHA 10 ML 2 ML 20 ML 3 ML (4 DIFFERENT PRODUCTS)
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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 Theracys, because FDA testing found microorganisms and fungal growth in the clean room where the products were prepared.
Product
THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 VIAL 1 VIALS 12 VIAL 12 VIALS 2 VIALS 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 6 VIAL 6 VIALS
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Drugs Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile ophthalmic drugs distributed between November 2011 and May 2012 because environmental sampling found microorganisms in the clean room.
Product
LIDOCAINE HCL/BUPIVACAINE HCL PF 1%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE HCL/BUPIVACAINE/HYALURONIDASE PF 0.83%/0.312%/16.67U/ML OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/BUPIVACAINE/HYALURONIDASE PF 1.776%/0.33
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling specific sterile injectable drugs because FDA sampling found microorganisms and fungal growth in the production clean room.
Product
TRIMIX/LIDOCAINE 11.8MG/0.39MG/10.6MCG/1.7MG/ML INJECTABLE 30 ML; TRIMIX/LIDOCAINE 13.6MG/0.45MG/38.2MCG/7.3MG/ML INJECTABLE 10 ML; TRIMIX/LIDOCAINE 12MG/1MG/5MCG/1%/ML INJECTABLE 10 MLS; TRIMIX/LIDOCAINE 17.65MG/0.59MG/5.9MCG/
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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 injectable drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
METHIONINE / INOSITOL / CHOLINE CHLORIDE 25MG/75MG/75MG/ML INJECTABLE 30 ML; METHIONINE/INOSITOL/CHOLINE CHLORIDE 0.8%/1.6%/1.6% INJECTABLE 180 ML 24 ML 240 ML 270 ML 30 ML 90 ML METHIONINE/INOSITOL/CHOLINE CHLORIDE 25MG/50MG/50MG/ML INJECTAB
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Ranibizumab Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling 19 units of Ranibizumab injectable because FDA testing found microorganisms in the clean room where the sterile drugs were prepared.
Product
RANIBIZUMAB, SDPF - (0.05ML SYRINGE, 31G, 5/16") 10MG/ML INJECTABLE 1 ML 1.25 ML 1.75 ML 2.3 ML 2.35 ML 20 ML 20.15 ML 20.45 ML 20.6 ML 20.9 ML 21.05 ML 21.2 ML 21.25 ML 21.45 ML 21.6 ML 21.7 ML 24.4 ML 28.1 ML (18 DIFFERENT PRODUCTS)
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Compounding Lab Recalls Morphine Sulfate Injectable Products
Franck's Compounding Lab is recalling 92 units of morphine sulfate injectable products due to a lack of assurance of sterility.
Product
MORPHINE SULFATE 2MG/ML INJECTABLE 10 ML; MORPHINE SULFATE MDV 10MG/ML INJECTABLE 10 ML 25 ML 30 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 50MG/ML INTRATHECAL 18 ML 40 ML; MORPHINE SULFATE, P.F. (0.9% SODIUM CHLORIDE) 15MG/ML INTRATHECAL 40 ML;
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Ophthalmic Solutions Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile ophthalmic solutions distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 ML (1 PRODUCT)
Category
Distribution
0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Mitomycin Injectable Drugs Due to Contamination
Franck's Lab Inc. is recalling sterile Mitomycin/Lidocaine/Epinephrine injectable drugs because FDA sampling found microorganisms and fungal growth in the clean room.
Product
MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.04%/0.02%/0.1% INJECTABLE 5 ML; MITOMYCIN/LIDOCAINE/EPINEPHRINE 0.08MG/13.3MG/6.7MCG/ML INJECTABLE 0.2 ML (2 DIFFERENT PRODUCTS)
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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
TRIMIX 9MG / 0.3MG /3.3MCG INJECTABLE 6 ML; TRIMIX 9MG / 0.3MG /6.6MCG INJECTABLE 6 ML; TRIMIX 9MG / 1MG / 10MCG INJECTABLE 10 ML; TRIMIX ((LYOPHILIZED)) - 2ML VIAL 30MG / 1MG / 10MCG INJECTABLE 10 ML 10 VIALS 2 ML 4 ML 50 ML; TRIMIX ((LYOPHILIZ
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Rubidium Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile Rubidium 200mcg/mL injectable products distributed between November 2011 and May 2012. The recall was initiated after FDA sampling found microorganisms and fungal growth in the clean room used for preparation.
Product
RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT)
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Pyridoxine Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Pyridoxine 100mg/mL Injectable products because FDA testing found microorganisms and fungal growth in the clean room where they were prepared.
Product
PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS)
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Voriconazole Ophthalmic Drugs Due to Sterility Concerns
Franck's Lab Inc. is recalling sterile voriconazole ophthalmic drugs distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
VORICONAZOLE OPHTHALMIC 1% (10MG/ML) SOLUTION 15 ML; VORICONAZOLE OPHTHALMIC, (0.5ML, LL SYRINGE), P.F. 0.1% (100MCG/0.1ML) INJECTABL 0.5 ML 1 ML 1.5 ML 2 ML 2.5 ML 5 ML; VORICONAZOLE OPHTHALMIC, P.F. (SINGLE DOSE ONLY) 0.1% (100MCG/0.
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Injectable Vitamins Due to Sterility Concerns
Franck's Lab Inc. is recalling 23 sterile injectable vitamin products because FDA sampling found microorganisms and fungal growth in the clean room where they were prepared.
Product
VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADIONE) 5MG/ML INJECTABLE 2 ML; VITAMIN A AQUEOUS EMULSION 50,000 U/ML INJECTABLE 20 ML 40 ML; VITAMIN B COMPLEX (B1,B2,B3,B5,B6) 100/5/100/100/100MG/ML INJECTABLE 120 ML 150 ML
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Isosulfan Blue Injectable Due to Sterility Concerns
Franck's Lab Inc. is recalling Isosulfan Blue 1% Injectable due to microorganisms and fungal growth found in the clean room where sterile products were prepared.
Product
ISOSULFAN BLUE 1% INJECTABLE 10 ML 15 ML (2 DIFFERENT PRODUCTS)
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0 states
SevereFDA (Drugs)··2012-08-22
Franck's Lab Recalls Sterile Pantothenic Acid Injectable Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile pantothenic acid injectable products distributed between November 2011 and May 2012 because FDA sampling found microorganisms and fungal growth in the clean room.
Product
PANTOTHENIC ACID 1MG/ML INJECTABLE 30 ML (1 PRODUCT)
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Distribution
0 states