FDA recall D-1064-2013

Product

Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.

Reason for recall

CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.

Distribution

Nationwide.

Key facts

Status

Terminated

Initiation date

2013-08-08

Report date

2013-10-09

Termination date

2014-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

New Castle, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1064-2013