June 2020 FDA Recall Metformin Hydrochloride Extended Release by Marksans Pharma Limited
D-1356-2020 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Marksans Pharma Limited on June 5, 2020 for the product Metformin Hydrochloride Extended Release. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1356-2020
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
06-05-2020
07-01-2020
11279 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Marksans Pharma Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-07-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01
Batch or Lot Expiration Information
Lot# XP9004, exp 12/2020
