Drug product
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).
D-020-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 62854
- Status
- Terminated
- Classification
- Class I
- Quantity
- 216,880 cartridge units
- Official record key
drug-enforcement:D-020-2013
Official wording
Reason: Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Code information: Lot 12720LL, Exp 12/01/13
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent