Actavis Recalls Ranitidine Syrup Due to Impurity Specification Failure
Actavis South Atlantic LLC is recalling 133,968 bottles of Ranitidine Syrup because the product failed an impurity specification for 'Related Compound C'.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any hospitalizations, deaths, or specific injuries, and the hazard is a specification failure rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Actavis South Atlantic LLC is recalling 133,968 bottles of Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. The product was manufactured by VistaPharm, Inc., in Birmingham, Alabama, and distributed by Actavis Mid Atlantic LLC in Lincolnton, North Carolina. The recall covers lot numbers 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300, and 284300.
The recall was initiated because the product failed an impurity/degradation specification for 'Related Compound C'. The affected units were distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions or to obtain a replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- 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
- Manufacturer
- Actavis South Atlantic LLC
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 133,968
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot Numbers: 247900
- 251000
- 256000
- 261200
- 263600
- 266700
- 277100
- 280300 and 284300.
Distribution
Distributed nationwide across the United States.
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