October 2020 FDA Recall Metformin Hydrochloride Extended Release by Direct Rx
D-0058-2021 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Direct Rx on October 12, 2020 for the product Metformin Hydrochloride Extended Release. The FDA reported the reason for recall as cgmp deviations. The product was distributed in FL and the recall is currently terminated.
Recall Number: D-0058-2021
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
10-12-2020
11-11-2020
88 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.
Direct Rx
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.
FL
09-22-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Batch or Lot Expiration Information
Lot# Lot: 04DE1902, 11DE1908 Exp. 06/30/2021
