Why it was recalled
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
Product description
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32
Lot numbers, UPCs & expiration codes
Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015
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-1604-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 9, 2014
- FDA report date
- Oct 1, 2014
- Quantity
- 373,180 Carpuject units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1604-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69163
- Address
- 275 N Field Dr
- Code information
- Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015
- Postal code
- 60045-2579
- Report date
- Oct 1, 2014
- Product type
- Drugs
- Recall number
- D-1604-2014
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 373,180 Carpuject units
- Termination date
- Mar 17, 2017
- Reason for recall
- Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or Intravenous Use, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2012-32
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 9, 2014
- Center classification date
- Sep 19, 2014