Why it was recalled
Failed Impurity/Degradation Specification; "Related Compound C"
Product description
Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA
Lot numbers, UPCs & expiration codes
Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.
Where it was sold
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-829-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2013
- FDA report date
- Aug 7, 2013
- Quantity
- A total of 133,968 bottles (units)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Actavis South Atlantic LLC
Original FDA data
Every field from FDA enforcement report D-829-2013, exactly as published.
Show all FDA fields
- City
- Sunrise
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65338
- Address
- 13800 Nw 2nd St Ste 190
- Code information
- Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.
- Postal code
- 33325-6243
- Report date
- Aug 7, 2013
- Product type
- Drugs
- Recall number
- D-829-2013
- Classification
- Class II
- Recalling firm
- Actavis South Atlantic LLC
- Product quantity
- A total of 133,968 bottles (units)
- Termination date
- May 15, 2014
- Reason for recall
- Failed Impurity/Degradation Specification; "Related Compound C"
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA
- Distribution pattern
- Nationwide
- Recall initiation date
- May 15, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 30, 2013