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Class II: temporary or reversible health riskTerminated

RIJ Pharmaceutical RPC APAP Elixir Recall

RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL

RIJ Pharmaceutical LLC · Middletown, NY

Risk level
Class II
Reported by FDA
Jun 20, 2018
Recall ID
D-0847-2018
Check your lot numberHow we source this data

Summary

RIJ Pharmaceutical recalled RPC APAP Elixir starting May 7, 2018. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0847-2018 on Jun 20, 2018. Reason: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Status: Terminated.

Why it was recalled

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 47080092, Exp 08/19

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0847-2018
Classification
Class II
Status
Terminated
Recall initiated
May 7, 2018
FDA report date
Jun 20, 2018
Quantity
228 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
RIJ Pharmaceutical LLC

Original FDA data

Every field from FDA enforcement report D-0847-2018, exactly as published.

Show all FDA fields
City
Middletown
State
NY
Status
Terminated
Country
United States
Event ID
80053
Address
40 Commercial Ave
Code information
Lot #: 47080092, Exp 08/19
Postal code
10941-1444
Report date
Jun 20, 2018
Product type
Drugs
Recall number
D-0847-2018
Classification
Class II
Recalling firm
RIJ Pharmaceutical LLC
Product quantity
228 bottles
Termination date
Apr 7, 2023
Reason for recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide in the USA
Recall initiation date
May 7, 2018
Initial firm notification
Letter
Center classification date
Jun 8, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0847-2018, published Jun 20, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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