RPC Children's Non-Aspirin — Class II drug recall D-0845-2018
Terminated recall by RIJ Pharmaceutical LLC, reported 2018-06-20, distributed nationwide. CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a
| Recall number | D-0845-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RIJ Pharmaceutical LLC, Middletown, NY, United States |
| Recall initiated | 2018-05-07 |
| Classified | 2018-06-08 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2023-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,272 bottles |
| Reason classes | microbial contamination, cgmp, specification failure |
| UPC / GTIN / UDI-DI | 00353807129048 |
| NDC | 53807-0129-04 |
| Lot numbers | 08/19, 47080091 |
Product
RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048
Reason for recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
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-0845-2018. 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.