Calvin Scott Recalls Topiramate 25mg Tablets Due to Packaging Defect
Calvin Scott & Company is recalling Topiramate 25mg tablets because light-sensitive drugs were repackaged in transparent pouches, violating CGMP standards.
What this means for you
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, and the hazard involves a packaging defect (transparent pouches for light-sensitive drugs) without reported illnesses or injuries, fitting the criteria for moderate severity.
Plain-English summary
Calvin Scott & Company, Inc. is recalling Topiramate 25mg tablets (NDC 47335-0707-13) distributed nationwide in the United States. The recall involves white, round tablets packaged in 10-count bags.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the light-sensitive drug products were repackaged in transparent or partially transparent pouches, which does not meet regulatory requirements for protecting the medication from light.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The specific lot number is 19234, and the expiration date is 9/20.
The recalled product
- Product
- Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13
- Manufacturer
- Calvin Scott & Company, Inc.
- Category
- Drug — Anticonvulsant
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 #: 19234
- Exp. Date: 9/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Calvin Scott & Company, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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