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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 8481–8500 of 17,773 recalls

Class IITerminated

Methyl-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

Auro Pharmacies, Inc.

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

August 21, 2018 · DrugView details →

Class IITerminated

Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631

Auro Pharmacies, Inc.

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

August 21, 2018 · DrugView details →

Class IITerminated

Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.

Hetero Labs Limited Unit V

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

August 20, 2018 · DrugView details →

Class IITerminated

Amlodipine/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

RemedyRepack Inc.

CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

August 20, 2018 · DrugView details →

Class IIOngoing

Amlodipine 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

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Amlodipine, 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

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Amlodipine 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

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Amlodipine, 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

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Amlodipine 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

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Amlodipine, 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

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Amlodipine 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

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Amlodipine, 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

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Class IIOngoing

Amlodipine, 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

Torrent Pharma Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 17, 2018 · DrugView details →

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30

Hetero Labs Limited Unit V

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

August 15, 2018 · DrugView details →

Class IITerminated

Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9

Preferred Pharmaceuticals, Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 15, 2018 · DrugView details →

Class IITerminated

Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478

AVKARE Inc.

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

August 14, 2018 · DrugView details →

Class IIITerminated

Valsartan Tablets USP, 320 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-363-90

Jubilant Cadista Pharmaceuticals, Inc.

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

August 14, 2018 · DrugView details →

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