Recalls / Class II
Class IID-1383-2020
Product
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09
- Brand name
- Metformin Hydrochloride
- Generic name
- Metformin Hydrochloride
- Active ingredient
- Metformin Hydrochloride
- Route
- Oral
- NDCs
- 68180-338, 68180-339
- FDA application
- ANDA091664
- Affected lot / code info
- Batch # G807093 Jul-20 G807147 Jul-20 G807208 Jul-20 G807479 Jul-20 G807480 Jul-20 G807830 Jul-20 G807092 Jul-20 G809471 Jul-20 G808155 Aug-20 G808074 Aug-20 G808115 Aug-20 G900231 Nov-20 G900232 Nov-20 G903277 Mar-21 G903278 Mar-21 G903279 Mar-21 G903280 Mar-21 G903281 Mar-21 G903818 Apr-21 G904048 Apr-21 G904164 Apr-21 G906548 Jul-21 G907239 Aug-21 G907255 Aug-21 G907256 Aug-21 G907263 Aug-21 G001802 Jan-22 G001804 Jan-22 G001803 Jan-22 G001805 Jan-22 G001806 Jan-22 G001807 Jan-22 G001808 Jan-22 G808154 Aug-20 G900227 Nov-20 G900228 Nov-20 G900229 Nov-20 G900230 Nov-20 G906549 Jul-21 G906550 Jul-21 G906547 Jul-21 G907279 Aug-21 G907364 Aug-21 G001809 Jan-22 G001801 Jan-22 G002563 Feb-22 G002564 Feb-22
Why it was recalled
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 95,886 bottles
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2020-07-07
- FDA classified
- 2020-07-14
- Posted by FDA
- 2020-07-22
- Terminated
- 2021-12-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1383-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.