FDA Recall
Terminated
Historical recordClass II
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 8 VIALS (13 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
TETRACAINE HCL OPHTHALMIC 0.05% SOLUTION 3 ML 6 ML; TETRACAINE HCL P.F. OPHTHALMIC 0.5% SOLUTION 30 ML (3 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
TAURINE 50MG/ML INJECTABLE 120 ML 30 ML 40 ML 60 ML (4 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SESAME OPHTHALMIC OIL 60 ML (1 PRODUCT)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED 9MG VIAL 1 VIAL 2 VIAL 3 VIAL 30 VIAL; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG KIT 1 KIT 3 KIT; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG VIAL 1 VIAL 3 VIAL 4 VIAL 7 VIAL (16 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SELENIUM 200MCG/ML INJECTABLE 150 ML 30 ML 60 ML (3 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
RUBIDIUM 200MCG/ML INJECTABLE 30 ML (1 PRODUCT)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
RIBOFLAVIN SOLUTION 0.1% OPHTHALMIC 10 ML 5 ML; RIBOFLAVIN SOLUTION, P.F. 0.1% OPHTHALMIC 90 ML (3 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
RANITIDINE 25MG/ML INJECTABLE 200 ML 480 ML 800 ML (3 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
QUADMIX 12MG/1MG/10MCG/150MCG/ML INJECTABLE 10 ML; QUADMIX 15MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/0.5MG/5MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/1MG/10MCG/100MCG/ML INJECTABLE 1 ML 10 ML 2 ML 30 ML 5 ML; QUADMIX 30MG/1MG/20MCG/100MCG/ML INJECTABLE 10 ML 10 MLS 5 ML; QUADMIX 30MG/1MG/40MCG/100MCG/ML INJECTABLE 10 ML; QUADMIX 30MG/2MG/20MCG/100MCG/ML INJECTABLE 10 ML 2 ML 4 ML; QUADMIX 30MG/2MG/40MCG/100MCG/ML INJECTABLE 10 ML 15 ML; QUADMIX 30MG/2MG/60MCG/100MCG/ML INJECTABLE 5 ML; QUADMIX 30MG/3MG/50MCG/100MCG/ML INJECTABLE 10 ML 2.5 ML; QUADMIX 30MG/4MG/60MCG/100MCG/ML INJECTABLE 5 ML; QUADMIX 30MG/6MG/60MCG/100MCG/ML INJECTABLE 5 ML (22 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PYRIDOXINE 100MG/ML INJECTABLE 150 ML 180 ML 300 ML 360 ML 450 ML (5 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PROGESTERONE AQUEOUS 2MG/ML INJECTABLE 3 ML; PROGESTERONE IN COTTONSEED OIL 50MG/ML INJECTABLE 30 ML; PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 200 ML; PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 1000 ML; PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 10 MLS 30 ML (6 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PREDNISOLONE ACETATE 10MG/ML INJECTABLE 10 MLS (1 PRODUCT)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
POVIDONE-IODINE/LIDOCAINE/TETRACAINE 4.6%/4%/0.5% OPHTHALMIC 30 ML (1 PRODUCT)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
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 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PILOCARPINE HCL P.F IN B.S.S OPHTHALMIC 1% INJECTABLE 36 ML; PILOCARPINE HCL SOLUTION 0.5% OPHTHALMIC 30 ML; PILOCARPINE HCL SOLUTION (PF) 0.5% OPHTHALMIC 30 ML (3 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLEPHRINE/TROPICAMIDE/PROPARACAINE SOLUTION 2.5%/1%/0.5% OPHTHALMIC 120 ML 25 ML 30 ML 5 ML 90 ML (5 DIFFERENT PRODUCTS)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PHENYLEPHRINE/TROPICAMIDE (P.F.) SOLUTION 2.5%/1% OPHTHALMIC 5 ML (1 PRODUCT)
by Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Reason
- 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.
- Published
- August 22, 2012
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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