Why it was recalled
Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0044-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 1, 2014
- FDA report date
- Oct 29, 2014
- Quantity
- 145,600 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0044-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69314
- Address
- 275 N Field Dr
- Code information
- Lot #: a) 260753F, 261403F, Exp 1FEB2015; 290153F, Exp 1MAY2015; b) 24-080-DD, Exp 1DEC2014; 25-475-DD, Exp 1JAN2015
- Postal code
- 60045-2579
- Report date
- Oct 29, 2014
- Product type
- Drugs
- Recall number
- D-0044-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 145,600 vials
- Termination date
- Mar 23, 2017
- Reason for recall
- Lack Of Assurance Of Sterility: Confirmed customer complaints of glass product container vials that may be broken or cracked.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 1, 2014
- Initial firm notification
- Letter
- Center classification date
- Oct 23, 2014