Why it was recalled
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Product description
Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)
Lot numbers, UPCs & expiration codes
Lot: 30-137-DK Exp. 1 DEC. 2022
Where it was sold
Distributed in the United States 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-0003-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2022
- FDA report date
- Oct 12, 2022
- Quantity
- 103,150 10 mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0003-2023, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 90903
- Address
- 235 East 42nd Street
- Code information
- Lot: 30-137-DK Exp. 1 DEC. 2022
- Postal code
- 10017-5703
- Report date
- Oct 12, 2022
- Product type
- Drugs
- Recall number
- D-0003-2023
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 103,150 10 mL vials
- Termination date
- Aug 21, 2024
- Reason for recall
- Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose vial, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA. NDC 0409-5921-16 (vial) 0409-5921-01 (carton)
- Distribution pattern
- Distributed in the United States and Puerto Rico.
- Recall initiation date
- Sep 27, 2022
- Initial firm notification
- Letter
- Center classification date
- Oct 4, 2022