AuroMedics Recalls Ranitidine Tablets Due to Empty Bottles
AuroMedics Pharma LLC is recalling one lot of Ranitidine Tablets USP, 150 mg, because some bottles were found to be empty.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a packaging defect (empty bottles) rather than a contamination or safety hazard.
Plain-English summary
AuroMedics Pharma LLC is recalling one lot of Ranitidine Tablets USP, 150 mg, 8-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where some bottles were found to be empty.
The affected product is identified by Lot # NBSB19001DA3 with an expiration date of 02/2021. The product was distributed nationwide within the United States by Dolgencorp, LLC. A total of 69,696 bottles are involved in this recall.
Consumers who have this specific lot of Ranitidine Tablets should stop using the product and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
- Manufacturer
- AuroMedics Pharma LLC
- Hazard
- Affected units
- 69,696
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 (2)
- Lot #: NBSB19001DA3
- Exp. date 02/2021
Distribution
Distributed nationwide across the United States.
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