FDA Recall D-1386-2020

Granules Pharmaceuticals Inc · Chantilly, VA

Class II Ongoing 2141 days on record

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

Product

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India

Lot / code: a) 100 count 4920003A/May-21 4920004A/Jun-21 4920005A/Jun-21 4920009A/Nov-21 4920010A/May-22 4920011A/Jun-22 4920012A/Jun-22 4920013A/Jul-22 4920014A/Jul-22 4920015A/Aug-22 4920016A/Jan-23 b) 500 count 4920005B/Jun-21

Quantity: a) 476,073 bottles; b) 2,100 bottles

Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Recall record

Recall number: D-1386-2020
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: US Nationwide
Recall initiated: 2020-07-03
Classified by FDA Center: 2020-07-14
FDA published: 2020-07-22
Recalling firm: Granules Pharmaceuticals Inc
Firm location: Chantilly, VA

Drug identification

Brand name(s): METFORMIN
Generic name(s): METFORMIN ER 500 MG
Manufacturer(s): Granules Pharmaceuticals Inc.
NDC(s): 70010-491, 70010-492
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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