RecallRadar

FDA Drug recall D-829-2013

Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only

On 2013-08-07 the FDA classified a Class II recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only by Actavis South Atlantic, citing failed Impurity/Degradation Specification; "Related Compound C".

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-829-2013
ClassificationClass II
Statusterminated
Initiated2013-05-15
Published2013-08-07
Last updated2026-09-13 11:51 UTC
CompanyActavis South Atlantic
DistributionUS

Product

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

Reason

Failed Impurity/Degradation Specification; "Related Compound C"

Identifiers

code_infoLot Numbers: 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300 and 284300.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-829-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.