Why it was recalled
Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Product description
Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08
Lot numbers, UPCs & expiration codes
Lot #: 1804012, Exp. 08/2019
Where it was sold
Nationwide within the United States
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-1436-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 6, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 1536 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Geritrex, LLC
Original FDA data
Every field from FDA enforcement report D-1436-2019, exactly as published.
Show all FDA fields
- City
- Middletown
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 82947
- Address
- 40 Commercial Ave
- Code information
- Lot #: 1804012, Exp. 08/2019
- Postal code
- 10941-1444
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1436-2019
- Classification
- Class II
- Recalling firm
- Geritrex, LLC
- Product quantity
- 1536 units
- Termination date
- Feb 21, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- May 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 28, 2019