Drug product
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).
D-1444-2012
Product summary
- Firm
- Hospira Inc.
- Event
- Event 61847
- Status
- Terminated
- Classification
- Class I
- Quantity
- 223,750 prefilled cartridge units
- Official record key
drug-enforcement:D-1444-2012
Official wording
Reason: 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.
Code information: Lot #07547LL, Exp 07/01/13
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Superpotent