The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1516-2020·Announced 2020-08-26

Calvin Scott Recalls Hydrochlorothiazide Tablets Due to Packaging Defect

Calvin Scott & Company is recalling Hydrochlorothiazide 50mg tablets because light-sensitive products were repackaged in transparent pouches, violating CGMP standards.

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 involves a CGMP deviation regarding packaging that may affect drug stability, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Calvin Scott & Company, Inc. is recalling Hydrochlorothiazide 50mg tablets, 14-count bags, 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 NDC 16729-0184-17 and includes Lot # 18252 and Lot # 19033, both with an expiration date of 10/20. The tablets were manufactured by Accord Healthcare, Inc. and distributed by Calvin Scott & Co., Inc. in Albuquerque, NM.

Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative medication. The FDA classifies this as a Class II recall.

The recalled product

Product
Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17
Manufacturer
Calvin Scott & Company, Inc.
Category
Drug — Prescription Medication
Hazard

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 (3)

  • Lot #: 18252
  • 19033
  • Exp. Date: 10/20

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.

See all 19 products in this recall →

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