Recalls / Class I
Class ID-1332-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.
- Affected lot / code info
- Lot #: a) 7801396, 7801398, 7801401, 7801406, Exp 08/16; 7801427, Exp 09/16; b) 7801089, 7801084, Exp 07/15; 7801110, Exp 08/15
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Mylan Institutional LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4901 Hiawatha Dr, Rockford, Illinois 61103-1287
Distribution
- Quantity
- a) 35,197 vials; b) 21,302 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-03-23
- FDA classified
- 2015-08-14
- Posted by FDA
- 2015-08-26
- Terminated
- 2016-05-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1332-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.