June 2020 FDA Recall Drug by Pd-rx Pharmaceuticals, Inc.
D-1307-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Pd-rx Pharmaceuticals, Inc. on June 5, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in United States and the recall is currently terminated.

Recall Number: D-1307-2020

Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Initiated
06-05-2020
Reported
06-24-2020
Quantity
3703 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85827
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.
PD-Rx 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-08-2021
Product Description About Product Description
Full technical description of the product.
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) 120 tablets (NDC: 43063-428-98); e) 180 tablets (NDC: 43063-428-93); f) 500 tablets (NDC: 53746-0178-05), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

Batch or Lot Expiration Information

Lot# Lots: a) D19C80, F19C39, H19A55, H19D56, I18E0 Exp. 06/30/2020; b) D19A66, E19C15, F19D60 Exp. 06/30/2020; c) E19D32, J18B83, C19D25, C19E78, D19C60, D19D64, F19B27, G19A31, G19C41, I19A56 Exp. 06/30/2020; d) E19C11, F19E33, I18E07 Exp. 06/30/2020; e) D19D56, F19A51, H19A09, H19A81, H19B16, H19B77, H19C28, I18F43 Exp. 06/30/2020; f) HF06618A, HF06718A Exp. 06/30/2020