November 2020 FDA Recall Drug by Preferred Pharmaceuticals, Inc.
D-0077-2021 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc. on November 1, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Distributed to two physician's offices located in FL. and the recall is currently terminated.

Recall Number: D-0077-2021

Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Initiated
11-01-2020
Reported
11-25-2020
Quantity
99 bottles (9990 Extended Release Tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86696
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Preferred Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to two physician's offices located in FL.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-20-2024
Product Description About Product Description
Full technical description of the product.
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.

Batch or Lot Expiration Information

Lot# E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022