Drug recall D-0044-2015
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.
Reason for recall
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Lots and codes
Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 145,600 vials
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 1, 2014
- Terminated
- March 23, 2017
Related products
- Hydromorphone Hydrochloride – drug information
- NDC 0703-0113 Hydromorphone Hydrochloride · Hydromorphone Hydrochloride 10 mg/mL · Teva Parenteral Medicines, Inc.
- NDC 0703-0018 Hydromorphone Hydrochloride · Hydromorphone Hydrochloride 10 mg/mL · Teva Parenteral Medicines, Inc.
- NDC 0703-0110 Hydromorphone Hydrochloride · Hydromorphone Hydrochloride 10 mg/mL · Teva Parenteral Medicines, Inc.
- NDC 0409-2634 Hydromorphone Hydrochloride · Hydromorphone Hydrochloride 10 mg/mL · Hospira, Inc.