Drug and pharmaceutical recalls
17728 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-DrugValidus Pharmaceuticals, Inc.Class IIIRocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
- 2018-09-05FDA-DrugValidus Pharmaceuticals, Inc.Class IIICalcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
- 2018-09-05FDA-DrugPfizer Global SupplyClass IIChildren s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
- 2018-09-05FDA-DrugAkorn, Inc.Class IIIAzelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide
- 2018-09-05FDA-DrugAuro Pharmacies, Inc.Class IIMethyl-Cobalamin injectable, 2 mg/mL, 30 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-DrugAuro Pharmacies, Inc.Class IIFolic Acid injectable, 10 mg/ml, 30 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-DrugAuro Pharmacies, Inc.Class IITestosterone Enanthate/Cypionate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, 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 IITestosterone Cypionate/Enanthate injectable, 200/50 mg/mL, packaged in a) 5 mL and 8 mL Multiple Dose vials, 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 IITestosterone Cypionate/Enanthate injectable, 126/54 mg/mL, packaged in a) 3 mL and b) 5 mL Multiple Dose vials, 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 IIMethyl-Cobalamin injectable, 10 mg/mL, 30 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-DrugAuro Pharmacies, Inc.Class IIMethyl-Cobalamin injectable, 5 mg/mL, 30 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-DrugAuro Pharmacies, Inc.Class IIMethyl-Cobalamin injectable, 1 mg/mL, packaged in a) 5 mL and b) 30 mL Multiple Dose vials, 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 IIGlutathione injectable, 200 mg/mL, 30 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-DrugAuro Pharmacies, Inc.Class IIDexpanthenol injectable, 250 mg/mL, 10 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 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.
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