Buprenorphine Hydrochloride Injection recall: Impurity Out of Spec
Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or…
Why was Buprenorphine Hydrochloride Injection recalled?
Failed Impurities/Degradation Specification: Out of Specification results for pseudobuprenorphine impurity at the 9-month stability time point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 35-730-LL, 35-745-LL, Exp: 1 FEB 2015
- Product
- Buprenorphine Hydrochloride Injection, CIII, 0.3 mg base/mL ,1 mL, 10 Carpuject Sterile Cartridge Units with Luer Lock, Slim-Paks, F Intramuscular or…
- Recalling firm
- Hospira Inc.
- Quantity
- 373,180 Carpuject units
- Distribution
- Nationwide
- Recall date
- October 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)