FDA Drug recall D-1064-2013
Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 101…
- FDA Drug
- Class II
- terminated
- Published 2013-10-09
On 2013-10-09 the FDA classified a Class II recall of Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 101… by Marlex Pharmaceuticals, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1064-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-08 |
| Published | 2013-10-09 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Marlex Pharmaceuticals |
| Distribution | US |
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
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.
Identifiers
| upc | 310135152018 |
|---|---|
| code_info | Lot #: 3213, Exp 12/13 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1064-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.