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 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
Lot numbers, UPCs & expiration codes
Lot #: 47080091, 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-0845-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 7, 2018
- FDA report date
- Jun 20, 2018
- Quantity
- 1272 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RIJ Pharmaceutical LLC
Original FDA data
Every field from FDA enforcement report D-0845-2018, 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 #: 47080091, Exp. 08/19
- Postal code
- 10941-1444
- Report date
- Jun 20, 2018
- Product type
- Drugs
- Recall number
- D-0845-2018
- Classification
- Class II
- Recalling firm
- RIJ Pharmaceutical LLC
- Product quantity
- 1272 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 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 8, 2018