Status
Terminated
Drug Enforcement D-829-2013
Failed Impurity/Degradation Specification; "Related Compound C"
Classification
Class II
Report Date
August 7, 2013
Termination Date
May 15, 2014
Product Information
- 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
- Product quantity
- A total of 133,968 bottles (units)
- Reason for recall
- Failed Impurity/Degradation Specification; "Related Compound C"
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Actavis South Atlantic LLC
- Address
-
13800 Nw 2nd St Ste 190, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-829-2013
- Event ID
- 65338
- Recall initiation date
- May 15, 2013
- Center classification date
- July 30, 2013
- Code info
- Lot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.
- More code info
- —