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.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IICalcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IICoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
- 2018-09-05FDA-DrugPharmcore Inc.Class IIIpamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lack of assurance of sterility.
- 2018-09-05FDA-DrugPharmcore Inc.Class IIMethylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lack of assurance of sterility.
- 2018-09-05FDA-DrugPharmcore Inc.Class IIIpamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lack of assurance of sterility.
- 2018-09-05FDA-DrugPharmcore Inc.Class IIHuman Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lack of assurance of sterility.
- 2018-09-05FDA-DrugPharmcore Inc.Class IIHuman Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lack of assurance of sterility.
- 2018-09-05FDA-DrugPharmcore Inc.Class IIHuman Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lack of assurance of sterility.
- 2018-09-05FDA-DrugPharmcore Inc.Class IIHuman Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lack of assurance of sterility.
- 2018-09-05FDA-DrugPharmcore Inc.Class IIHuman Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lack of assurance of sterility.
- 2018-09-05FDA-DrugPharmcore Inc.Class IIHuman Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
Lack of assurance of sterility.
- 2018-09-05FDA-DrugRemedyRepack Inc.Class IIAmlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIAmlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIAmlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-328-30
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIAmlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-327-30
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIAmlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIAmlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-325-30
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIAmlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-207-30
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIAmlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-206-30
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIAmlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-205-30
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIAmlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIValsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIValsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugTorrent Pharma Inc.Class IIValsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugAVKARE Inc.Class IIValsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugAVKARE Inc.Class IIValsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugAVKARE Inc.Class IIValsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugAVKARE Inc.Class IIValsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- 2018-09-05FDA-DrugMayne Pharma IncClass IIIOxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
- 2018-09-05FDA-DrugBaxter Healthcare CorporationClass II0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
CGMP Deviations
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