Class II · Moderate risk Terminated
Ranitidine 300 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Ranitidine Syrup
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurity/Degradation Specification; "Related Compound C"
What was recalled
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
- Recalling firm
- Actavis South Atlantic LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-829-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Ranitidine recalls
See all
Class II · Moderate risk Terminated
Ranitidine 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Ranitidine Hydrochloride
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
ranitidine hydrochloride
Reason CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II · Moderate risk Terminated
Preferred Pharmaceuticals
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
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