CVS Acid Controller Tablets Recalled for Impurity Specification Failure
Dr. Reddy's is recalling CVS pharmacy Acid Controller tablets because stability testing revealed an out-of-specification impurity.
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, fitting the Low severity criteria for documentation or specification issues without reported harm.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottles. The recall involves 84,240 bottles distributed nationwide. The specific products are identified by Lot # 79405008A, 79405008B, and 79405008C, with an expiration date of 05/2017.
The recall was initiated because stability testing at the 18th month interval determined that an individual related substance failed to meet the impurities/degradation specification for the Famotidine 10 mg Tablet, USP. The U.S. Food and Drug Administration has classified this recall as Class III.
Consumers who have these specific bottles should stop using the product and return it to the place of purchase for a refund. The recall is limited to the specific lot numbers and expiration date listed above.
The recalled product
- Product
- CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Hazard
- Affected units
- 84,240
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 (4)
- Lot # 79405008A
- 79405008B
- 79405008C
- Exp 05/2017
Distribution
Distributed nationwide across the United States.
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