Calvin Scott Recalls Hydrochlorothiazide Tablets Due to Packaging Defect
Calvin Scott & Company is recalling Hydrochlorothiazide 25mg tablets because light-sensitive products were repackaged in transparent pouches.
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, and the hazard involves a packaging deviation (transparent pouches for light-sensitive drugs) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Calvin Scott & Company, Inc. is recalling Hydrochlorothiazide 25mg tablets (NDC 16729-0183-17) distributed nationwide in the United States. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where light-sensitive drug products were repackaged in transparent or partially transparent pouches.
The affected product is identified by Lot # 19355 and an expiration date of 3/21. The tablets were manufactured by Accord Healthcare, Inc. in Durham, NC, and distributed by Calvin Scott & Co., Inc. in Albuquerque, NM.
Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recall details, they should contact their pharmacist or healthcare provider for guidance on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17
- Manufacturer
- Calvin Scott & Company, Inc.
- Category
- Drug — Prescription Medication
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 #: 19355
- Exp. Date: 3/21
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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