Recalls / Class II
Class IID-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.
- Brand name
- Hydromorphone Hydrochloride
- Generic name
- Hydromorphone Hydrochloride
- Active ingredient
- Hydromorphone Hydrochloride
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 0703-0018, 0703-0110, 0703-0113, 0409-2634
- FDA application
- ANDA078591
- Affected lot / code info
- Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015
Why it was recalled
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Teva Parenteral Medicines, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 145,600 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-10-01
- FDA classified
- 2014-10-23
- Posted by FDA
- 2014-10-29
- Terminated
- 2017-03-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0044-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.