FDA recall D-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

Reason for recall

Failed Dissolution Test Requirements

Distribution

FL, NJ.

Key facts

Status

Terminated

Initiation date

2012-11-20

Report date

2013-02-20

Termination date

2013-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-160-2013