Why it was recalled
Presence of Particulate Matter
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: a) 7801396, 7801398, 7801401, 7801406, Exp 08/16; 7801427, Exp 09/16; b) 7801089, 7801084, Exp 07/15; 7801110, Exp 08/15
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1332-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 23, 2015
- FDA report date
- Aug 26, 2015
- Quantity
- a) 35,197 vials; b) 21,302 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Institutional LLC
Original FDA data
Every field from FDA enforcement report D-1332-2015, exactly as published.
Show all FDA fields
- City
- Rockford
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71004
- Address
- 4901 Hiawatha Dr
- Code information
- Lot #: a) 7801396, 7801398, 7801401, 7801406, Exp 08/16; 7801427, Exp 09/16; b) 7801089, 7801084, Exp 07/15; 7801110, Exp 08/15
- Postal code
- 61103-1287
- Report date
- Aug 26, 2015
- Product type
- Drugs
- Recall number
- D-1332-2015
- Classification
- Class I
- Recalling firm
- Mylan Institutional LLC
- Product quantity
- a) 35,197 vials; b) 21,302 vials
- Termination date
- May 20, 2016
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Mar 23, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2015