FDA Recall D-1100-2020

Teva Pharmaceuticals USA · Parsippany, NJ

Class II Ongoing 2241 days on record

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

Product

LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00

Lot / code: Lots 1207344A, exp. date 06/2020; 1207343A, 1207342A, exp. date 07/2020

Quantity: N/A

Reason for recall

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Recall record

Recall number: D-1100-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Bulk product was distributed to one re-packager in California.
Recall initiated: 2020-03-25
Classified by FDA Center: 2020-04-07
FDA published: 2020-04-15
Recalling firm: Teva Pharmaceuticals USA
Firm location: Parsippany, NJ

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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