September 2017 FDA Recall Drug by Pfizer Manufacturing Deutschland Gmbh
D-0212-2018 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Pfizer Manufacturing Deutschland Gmbh on September 27, 2017 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed in Germany; products were packaged at the Pfizer Manufacturing Deutshland Gmbh location and then distributed to other countries. No product distributed in the United States or its territories. and the recall is currently terminated.

Recall Number: D-0212-2018

Reason for Recall
Microbial Contamination of Non-Sterile Products
Initiated
09-27-2017
Reported
01-17-2018
Quantity
a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78682
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.
Pfizer Manufacturing Deutschland GmbH
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.
Germany; products were packaged at the Pfizer Manufacturing Deutshland Gmbh location and then distributed to other countries. No product distributed in the United States or its territories.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-11-2020
Product Description About Product Description
Full technical description of the product.
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING

Batch or Lot Expiration Information

Lot# Bulk Product
Lot# ( Packaged
Lot# ) a) S55350 Exp. 20 APR 2018, S55378 Exp. 07 MAR 2018, S55386 Exp. 14 MAR 2018, S53284 Exp.14 FEB 2018, S53283 Exp. 10 FEB 2018; b) S53287 Exp. 16 FEB 2018, S33417 Exp. 03 FEB 2018; c) S33445 Exp. 17 FEB 2018, S33452 Exp. 24 FEB 2018; d) S33397 Exp. 07 FEB 2018