FDA Drug recall D-919-2013
ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0…
- FDA Drug
- Class I
- terminated
- Published 2013-09-04
On 2013-09-04 the FDA classified a Class I recall of ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0… by Advance Pharmaceutical, citing labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contai….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-919-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-06-17 |
| Published | 2013-09-04 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Advance Pharmaceutical |
| Distribution | US |
Product
ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.
Reason
Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.
Identifiers
| upc | 305363086419 |
|---|---|
| code_info | Lot #: 13A026, Exp 01/15 |
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-919-2013%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.