Status
Terminated
Drug Enforcement D-160-2013
Failed Dissolution Test Requirements
Classification
Class II
Report Date
February 20, 2013
Termination Date
July 12, 2013
Product Information
- Product description
- 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
- Product quantity
- 60 bottles
- Reason for recall
- Failed Dissolution Test Requirements
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- FL, NJ.
Location & Firm
- Recalling firm
- Upsher Smith Laboratories, Inc.
- Address
-
6701 Evenstad Drive
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-160-2013
- Event ID
- 63908
- Recall initiation date
- November 20, 2012
- Center classification date
- February 8, 2013
- Code info
- Lot #308198, Expiration Date is 03/2014
- More code info
- —