April 2021 FDA Recall Drug by Preferred Pharmaceuticals, Inc.
D-0385-2021 - CMGP Deviations

This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc. on April 28, 2021 for the product Drug. The FDA reported the reason for recall as cmgp deviations. The product was distributed in Distributed to two physician consignees located in FL. and the recall is currently ongoing.

Recall Number: D-0385-2021

Reason for Recall
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Initiated
04-28-2021
Reported
05-26-2021
Quantity
147 bottles (14,700 extended release tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87833
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.
Ongoing
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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Distributed to two physician consignees located in FL.
Product Description About Product Description
Full technical description of the product.
Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1

Batch or Lot Expiration Information

Lot# Lot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022