January 2020 FDA Recall Drug by Pd-rx Pharmaceuticals, Inc.
D-0826-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Pd-rx Pharmaceuticals, Inc. on January 10, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN and the recall is currently terminated.

Recall Number: D-0826-2020

Reason for Recall
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Initiated
01-10-2020
Reported
02-12-2020
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84820
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AZ, CA, FL, IL, IN, KY, ME, MS, OK, OR, PA, TN
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-23-2021
Product Description About Product Description
Full technical description of the product.
ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

Batch or Lot Expiration Information

Lot# a) H19E83 Exp. 11/30/2020, E19A82 Exp. 05/31/2020; b) H19B20 Exp. 11/30/2020, G19D77 Exp. 05/31/2020, C19D84 Exp. 05/31/2020, D19A77 Exp. 05/31/2020, D19E40 Exp. 05/31/2020; c) I19C45 Exp. 11/30/2020, E19E42 Exp. 11/30/2020, G19B41 Exp. 11/30/2020, H19C77 Exp. 11/30/2020, E19A34 Exp. 05/31/2020; d) H19B61 Exp. 11/30/2020, H19C82 Exp. 11/30/2020, C19A18 Exp. 05/31/2020, C19B13 Exp. 05/31/2020, D19B77 Exp. 05/31/2020, E19B76 Exp. 05/31/2020; e) I19B41 Exp. 11/30/2020, D19D51 Exp. 05/31/2020, F19C33 Exp. 05/31/2020