FDA Recall D-1036-2019

Aurobindo Pharma USA Inc. · East Windsor, NJ

Class II Ongoing 2691 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ Manufactured by: Aurobindo Pharma Limited, India --- NDC 65862-739-30

Lot / code: Lot Numbers: VFSA17007-A, exp. date Oct-2019

Quantity: N/A

Reason for recall

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Recall record

Recall number: D-1036-2019
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Product was distributed to major distribution chains throughout the United States.
Recall initiated: 2018-12-31
Classified by FDA Center: 2019-03-21
FDA published: 2019-03-27
Recalling firm: Aurobindo Pharma USA Inc.
Firm location: East Windsor, NJ

Drug identification

Brand name(s): AMLODIPINE AND VALSARTAN
Generic name(s): AMLODIPINE AND VALSARTAN
Manufacturer(s): Aurobindo Pharma Limited
NDC(s): 65862-737, 65862-739, 65862-738, 65862-740
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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