Why it was recalled
Lack of assurance of sterility: loss of container integrity.
Product description
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
Lot numbers, UPCs & expiration codes
Lot: 609G047, EXP 10/2018
Where it was sold
Nationwide in the US 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-0095-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 20, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 71,075 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0095-2019, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 81311
- Address
- 235 E 42nd St
- Code information
- Lot: 609G047, EXP 10/2018
- Postal code
- 10017-5703
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0095-2019
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 71,075 vials
- Termination date
- Sep 17, 2022
- Reason for recall
- Lack of assurance of sterility: loss of container integrity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
- Distribution pattern
- Nationwide in the US and Puerto Rico
- Recall initiation date
- Sep 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 24, 2018