FDA-Drug2013-10-09Class II

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.

Marlex Pharmaceuticals, Inc.
Hazard

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.

Sold states
Nationwide.
Affected count
28,387 bottles
Manufactured in
50 McCullough Dr, Southgate Industrial Park, New Castle, DE, United States
Products
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.

Official notice

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

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