Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIHydroxocobalamin 25mg/mL, 10mL-vial, Room Temperature, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIGonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIGlycyrrhizic Acid 8mg/mL, 10mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIGlutathione 200mg/mL Preservative Free, Injectable, 30mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIGOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml) 30 ml-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIGAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIFolic Acid 5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIEstradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIDexpanthenol Preservative Free 250mg/mL, 2mL-vial, Room Temperature, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIDexpanthenol 250mg/mL, 30mL-vial, Room Temperature, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IICalcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIBiotin 5mg/mL, 5mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIBCAAs (Leucine/Iso-Leucine/Valine) 10mg/10mg/5mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIAscorbic Acid 500mg/mL, a) 25 ml-vial, b) 50 ml-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIAnastrozole/Testosterone Cypionate/Propionate 1mg/160mg/40mg/mL, 10 mL-vial, Room Temperature, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIAlprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL, 3mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugTMC Acquisition LLC dba Tailor Made CompoundingClass IIAlpha Lipoic Acid 25mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Lack of Assurance of Sterility
- 2022-07-20FDA-DrugVi-Jon, LLCClass IIHydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 59779-871-45, UPC 0-50428-40950-3
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
- 2022-07-20FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IITestosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40.
cGMP - Water leakage
- 2022-07-20FDA-DrugJubilant Draximage IncClass IIDraximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30.
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
- 2022-07-20FDA-DrugBryant Ranch Prepack, Inc.Class IMorphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
- 2022-07-20FDA-DrugBryant Ranch Prepack, Inc.Class IMorphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01.
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
- 2022-07-13FDA-DrugWedgewood Village Pharmacy, LLCClass IIEstriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
- 2022-07-13FDA-DrugWedgewood Village Pharmacy, LLCClass IIEstriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
- 2022-07-13FDA-DrugWedgewood Village Pharmacy, LLCClass IIBoric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
- 2022-07-13FDA-DrugWedgewood Village Pharmacy, LLCClass IIBoric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
- 2022-07-13FDA-DrugWedgewood Village Pharmacy, LLCClass IIDoxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension bottles, Peppermint, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Dr, Ste 200, Swedesboro, NJ 08085
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
- 2022-07-13FDA-DrugWedgewood Village Pharmacy, LLCClass IIBethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
- 2022-07-13FDA-DrugGolden State Medical Supply Inc.Class IIEnalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
CGMP Deviations
- 2022-07-13FDA-DrugGolden State Medical Supply Inc.Class IIEnalapril Maleate Tablets, USP; 10 mg; 90 tablets, NDC 60429-185-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
CGMP Deviations
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