Why it was recalled
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Product description
HYDROmorphone HCl Injection, USP, 2 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 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).
Lot numbers, UPCs & expiration codes
Lot 12720LL, Exp 12/01/13
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-020-2013
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 15, 2012
- FDA report date
- Oct 31, 2012
- Quantity
- 216,880 cartridge units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-020-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 62854
- Address
- 275 N Field Dr
- Code information
- Lot 12720LL, Exp 12/01/13
- Postal code
- 60045-2579
- Report date
- Oct 31, 2012
- Product type
- Drugs
- Recall number
- D-020-2013
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 216,880 cartridge units
- Termination date
- May 29, 2015
- Reason for recall
- Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has 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, 2 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 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 15, 2012
- Initial firm notification
- Press Release
- Center classification date
- Oct 24, 2012