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
Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088
Lot numbers, UPCs & expiration codes
Lot #: 47060011, 47070031, 47070041, Exp. 09/18; 47080031, Exp.10/18
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-0850-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 7, 2018
- FDA report date
- Jun 20, 2018
- Quantity
- 31411 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RIJ Pharmaceutical LLC
Original FDA data
Every field from FDA enforcement report D-0850-2018, 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 #: 47060011, 47070031, 47070041, Exp. 09/18; 47080031, Exp.10/18
- Postal code
- 10941-1444
- Report date
- Jun 20, 2018
- Product type
- Drugs
- Recall number
- D-0850-2018
- Classification
- Class II
- Recalling firm
- RIJ Pharmaceutical LLC
- Product quantity
- 31411 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
- Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Jun 8, 2018