ENTERIC COATED ASPIRIN — Class I drug recall D-919-2013
Terminated recall by Advance Pharmaceutical Inc, reported 2013-09-04, distributed nationwide. Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labele
| Recall number | D-919-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Advance Pharmaceutical Inc, Holtsville, NY, United States |
| Recall initiated | 2013-06-17 |
| Classified | 2013-08-23 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2016-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 16,440 bottles |
| Reason classes | labeling |
| NDC | 00536-3086-41 |
| Lot numbers | 01/15, 13A026 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-919-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.