Recall Enforment Report D-0851-2021

Drug Recall Enforcement Report Class II voluntary initiated by Viatris, originally initiated on 08-23-2021 for the product Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01 The product was recalled due to failed dissolution specifications. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 88542 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0851-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification 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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description Lyrica CR (pregabalin) extended release tablets, 330 mg, 30-count bottles, Rx only, Distributed by Parke-Davis Division of Pfizer Inc., NY, NY 10017, NDC 0071-1029-01
Reason For Recall Failed Dissolution Specifications What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 9,515 bottles Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 10-06-2021
Recall Initiation Date 08-23-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Viatris
Code Info Lot #: DN5396, EP9726, EK2417, Exp. Date August 2022 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 0071-1026-01; 0071-1027-01; 0071-1029-01
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0071-1026Lyrica Cr PregabalinTablet, Film Coated, Extended ReleaseOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1027Lyrica Cr PregabalinTablet, Film Coated, Extended ReleaseOralParke-davis Div Of Pfizer IncHuman Prescription Drug
0071-1029Lyrica Cr PregabalinTablet, Film Coated, Extended ReleaseOralParke-davis Div Of Pfizer IncHuman Prescription Drug