Why it was recalled
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Product description
HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit).
Lot numbers, UPCs & expiration codes
Lot #07547LL, Exp 07/01/13
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-1444-2012
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 12, 2012
- FDA report date
- Aug 15, 2012
- Quantity
- 223,750 prefilled cartridge units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1444-2012, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 61847
- Address
- 275 N Field Dr
- Code information
- Lot #07547LL, Exp 07/01/13
- Postal code
- 60045-2579
- Report date
- Aug 15, 2012
- Product type
- Drugs
- Recall number
- D-1444-2012
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 223,750 prefilled cartridge units
- Termination date
- May 29, 2015
- Reason for recall
- Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit).
- Distribution pattern
- Nationwide.
- Recall initiation date
- May 12, 2012
- Initial firm notification
- Press Release
- Center classification date
- Aug 7, 2012