D-020-2013 Class I Terminated
FDA drug recall D-020-2013 was initiated by Hospira Inc. on Aug 15, 2012 and is designated Class I. 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. The recall status is terminated (terminated May 29, 2015). Affected quantity: 216,880 cartridge units.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 31, 2012
- Initiation Date
- Aug 15, 2012
- Termination Date
- May 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 216,880 cartridge units
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).
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.
Distribution Pattern
Nationwide
Code Information
Lot 12720LL, Exp 12/01/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-020-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026