CLASS II Drug recall · Reported 20 Jun 2018 · FDA Enforcement Report
RPC APAP Elixir (Acetaminophen 160mg) recalled by RIJ Pharmaceutical
RIJ Pharmaceutical is recalling RPC APAP Elixir (Acetaminophen 160mg), distributed nationwide in the US. The recall was initiated on 7 May 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0847-2018
- FDA event ID
- 80053
- Recalling firm
- RIJ Pharmaceutical, Middletown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 May 2018
- FDA classified
- 8 Jun 2018
- Reported
- 20 Jun 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 7 May 2018 | Recall initiated by company | |
| 8 Jun 2018 | Classified by FDA | +32 days |
| 20 Jun 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Which lots are affected?
Lot #: 47080092, Exp 08/19
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
11 other products · FDA event 80053This product is part of a recall event; the main page for the event is Geritrex Senna Syrup (sennosides 8.8mg) recalled by RIJ Pharmaceutical.
More recalls from RIJ Pharmaceutical
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg recalled | RIJ Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | SDA Senna Syrup (Sennosides 8.8mg) recalled by RIJ PharmaceuticalSenna Syrup | RIJ Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Ritussin DM Dextromethorphan Hydrobormide recalled by RIJ Pharmaceutical | RIJ Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | GeriCare Senna Syrup (Sennosides 8.8 mg), Dist recalled | RIJ Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg recalled | RIJ Pharmaceutical | Potency & Assay | Nationwide |