FDA recall D-0839-2016

Product

Acetaminophen & Codeine Phosphate Tablets, 300 mg/30 mg, 15-count plastic bottle, Rx only, Mfr: Aurolife Pharma LLC, Dayton NJ, Packaged Exclusively by: A-S Medication Solutions LLC, Libertyville, ILL 60048, NDC 54569-8305-0

Reason for recall

Labeling: Not elsewhere classified - count on the label was incorrect.

Distribution

Virginia

Key facts

Status

Terminated

Initiation date

2016-04-22

Report date

2016-05-11

Termination date

2016-10-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Libertyville, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0839-2016