FDA Recall D-0632-2020

Granules India Limited · Qutbullapur Mandal, Ranga Redd, N/A

Class II Ongoing 2344 days on record

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

Product

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

Lot / code: 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A

Quantity: 23,090,000 tablets

Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Recall record

Recall number: D-0632-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: OR, NY, NJ
Recall initiated: 2019-12-13
Classified by FDA Center: 2019-12-29
FDA published: 2020-01-08
Recalling firm: Granules India Limited
Firm location: Qutbullapur Mandal, Ranga Redd, N/A, India

Drug identification

Brand name(s): RANITIDINE
Generic name(s): RANITIDINE
Manufacturer(s): Granules India Ltd
NDC(s): 62207-773, 62207-774
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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