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.
Reported: October 9, 2013 Initiated: August 8, 2013 #D-1064-2013
Product Description
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.
Details
- Recalling Firm
- Marlex Pharmaceuticals, Inc.
- Units Affected
- 28,387 bottles
- Distribution
- Nationwide.
- Location
- New Castle, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Marlex Pharmaceuticals, Inc.. Units affected: 28,387 bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2013. Severity: Moderate. Recall number: D-1064-2013.
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