Recalls / Class II
Class IID-160-2013
Product
Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
- Affected lot / code info
- Lot #308198, Expiration Date is 03/2014
Why it was recalled
Failed Dissolution Test Requirements
Recalling firm
- Firm
- Upsher Smith Laboratories, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 6701 Evenstad Drive, Maple Grove, Minnesota 55369
Distribution
- Quantity
- 60 bottles
- Distribution pattern
- FL, NJ.
Timeline
- Recall initiated
- 2012-11-20
- FDA classified
- 2013-02-08
- Posted by FDA
- 2013-02-20
- Terminated
- 2013-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-160-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.