Status
Terminated
Drug Enforcement D-1444-2012
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.
Classification
Class I
Report Date
August 15, 2012
Termination Date
May 29, 2015
Product Information
- 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).
- Product quantity
- 223,750 prefilled cartridge units
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1444-2012
- Event ID
- 61847
- Recall initiation date
- May 12, 2012
- Center classification date
- August 7, 2012
- Code info
- Lot #07547LL, Exp 07/01/13
- More code info
- —