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.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIPAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIPAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIPAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIMethylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIMethylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIHydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIProstaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)10 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205 (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IIHydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 mL. b) 9.6 mL, c) 10.8mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b) 12 mL vials, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343- 6252.
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugFirst Pharma Associates LLC dba Riverpoint PharmacyClass IITestosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, First Pharma Associates dba Riverpoint Pharmacy, Spokane, WA 99205, (509) 343-6252
Lack of Assurance of Sterility.
- 2019-07-17FDA-DrugAmerican Health PackagingClass IIAnastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
- 2019-07-17FDA-DrugMAJOR PHARMACEUTICALSClass IILosartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
- 2019-07-17FDA-DrugGolden State Medical Supply Inc.Class IILosartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugGolden State Medical Supply Inc.Class IILosartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugGolden State Medical Supply Inc.Class IILosartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugGolden State Medical Supply Inc.Class IILosartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugMacleods Pharma Usa IncClass IILosartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugMacleods Pharma Usa IncClass IILosartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-051-10
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugMacleods Pharma Usa IncClass IILosartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugMacleods Pharma Usa IncClass IILosartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-44
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugMacleods Pharma Usa IncClass IILosartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugTeva Pharmaceuticals USAClass IILOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-17FDA-DrugTeva Pharmaceuticals USAClass IILOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- 2019-07-10FDA-DrugPharMEDium Services, LLCClass IHydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78
Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
- 2019-07-10FDA-DrugInvaGen Pharmaceuticals, Inc.Class IIITestosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44
Defective Container; actuator may improperly function and affect dose delivery.
- 2019-07-10FDA-DrugAmneal Pharmaceuticals, Inc.Class IIIEsterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
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