February 2018 FDA Recall Drug by Aurobindo Pharma Ltd.
D-0427-2018 - Presence of Foreign Tablet
This Class III drug recall was voluntarily initiated by Aurobindo Pharma Ltd. on February 2, 2018 for the product Drug. The FDA reported the reason for recall as presence of foreign tablet. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0427-2018
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
02-02-2018
02-28-2018
7476 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Aurobindo Pharma Ltd.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the US
02-18-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05.
Batch or Lot Expiration Information
Lot# : MTSC17145-A, Exp. July 2021
