FDA Drug recall D-0847-2018
RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDL…
- FDA Drug
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDL… by Rij Pharmaceutical, citing CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0847-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-07 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rij Pharmaceutical |
| Distribution | US |
Product
RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161
Reason
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Identifiers
| upc | 353807129161 |
|---|---|
| code_info | Lot #: 47080092, Exp 08/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0847-2018%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.