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.
- 2021-11-03FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIIAllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15
Failed Moisture Limits
- 2021-11-03FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIILoratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
Failed Moisture Limits
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IISODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIPROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMETHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMETHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMETHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIMETHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIFOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IICALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIBENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIVIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIVIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IITESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IITEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IITEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IITEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IITEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IITEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IITEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IITEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IITEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IIPYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
- 2021-11-03FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass IILEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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