Drug product
Hydromorphone Hydrochloride Injection, USP, 10 mg/mL, Rx only, packaged in a) 1 mL Single-dose Vial (NDC 0703-0110-01), packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0703-0110-03); Mfd By: Hospira Inc., Lake Forest, IL 60045; Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618; and b) 1 mL Single-dose Vial, packaged in 10 x 1 mL Single-dose Vials per carton (NDC 0409-2634-01), Hospira, Inc., Lake Forest, IL 60045.
D-0044-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 69314
- Status
- Terminated
- Classification
- Class II
- Quantity
- 145,600 vials
- Official record key
drug-enforcement:D-0044-2015
Official wording
Reason: Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Code information: Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack Of Assurance Of Sterility