Class II
Ongoing
Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
This recall is currently active, issued August 1, 2018. It was issued by Teva Pharmaceuticals Usa.
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- July 16, 2018
- Posted
- August 1, 2018
- Recall Number
- D-0988-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 15,347 90-count bottles, 8,378 1000-count bottles
- Firm Location
- North Wales, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Lot / Code Info
NDC 0591-2169-19 Lot Numbers: 1177880A, 1220831A, 1263941A NDC 0591-2169-10 1175922M, 1220826M, 1236294M, 1240427M, 1270616A
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