November 2016 FDA Recall Metformin Hydrochloride by Ascend Laboratories Llc
D-0163-2017 - Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
This Class II drug recall was voluntarily initiated by Ascend Laboratories Llc on November 2, 2016 for the product Metformin Hydrochloride. The FDA reported the reason for recall as presence of foreign tablets/capsules; report of amlodipine tablets found in 1000 count bottles of metformin hydrochloride tablets usp. The product was distributed in AL, FL, GA, SC & TN and the recall is currently terminated.
Recall Number: D-0163-2017
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
11-02-2016
12-07-2016
1739 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.
Ascend Laboratories LLC
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.
AL, FL, GA, SC & TN
06-07-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10
Batch or Lot Expiration Information
Lot# Lot 6121056, exp 5/2019
