Why it was recalled
cGMP Deviations: Products may have microbial contamination.
Product description
Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04
Lot numbers, UPCs & expiration codes
Lot #: 70602, Exp 6/19
Where it was sold
U.S.A. Nationwide
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-1521-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 31, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- 5107 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Geritrex, LLC
Original FDA data
Every field from FDA enforcement report D-1521-2019, exactly as published.
Show all FDA fields
- City
- Middletown
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 83200
- Address
- 40 Commercial Ave
- Code information
- Lot #: 70602, Exp 6/19
- Postal code
- 10941-1444
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1521-2019
- Classification
- Class II
- Recalling firm
- Geritrex, LLC
- Product quantity
- 5107 bottles
- Termination date
- Feb 2, 2024
- Reason for recall
- cGMP Deviations: Products may have microbial contamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- May 31, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 25, 2019