Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Product description
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
Lot numbers, UPCs & expiration codes
Lot# 26-138-JT; Exp. 08/14
Where it was sold
Nationwide
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-461-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 30, 2013
- FDA report date
- Jan 22, 2014
- Quantity
- 17,256 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-461-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 66147
- Address
- 275 N Field Dr
- Code information
- Lot# 26-138-JT; Exp. 08/14
- Postal code
- 60045-2579
- Report date
- Jan 22, 2014
- Product type
- Drugs
- Recall number
- D-461-2014
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 17,256 containers
- Termination date
- Aug 21, 2015
- Reason for recall
- Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 30, 2013
- Initial firm notification
- Press Release
- Center classification date
- Jan 13, 2014