The Recall Desk
ModerateFDA (Drugs)·D-1519-2020·Announced 2020-08-26

Calvin Scott Recalls Thyroid Neutral Tabs Due to Packaging Deviation

Calvin Scott & Company is recalling Thyroid Neutral Tabs 2 gr because light-sensitive tablets 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, which typically indicates a violation of CGMPs that could cause temporary or medically reversible health consequences. The hazard is a packaging deviation (light sensitivity) rather than a direct contamination or mislabeling of a common allergen, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Calvin Scott & Company, Inc. is voluntarily recalling Thyroid Neutral Tabs 2 gr, 28-count tablets (NDC 64727-3308-02). The recall involves Lot #19286 with an expiration date of 01/21. The product is distributed nationwide within the United States.

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 exposure.

Consumers who have this specific lot of Thyroid Neutral Tabs should stop using the product and contact their healthcare provider or pharmacist for guidance. The product is prescription-only, so patients should consult their prescriber regarding alternative treatments or replacements.

The recalled product

Product
Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, MN 87123, Manufactured by RLC, Cave Creek, AZ 85331 Labs, NDC 64727-3308-02
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 (2)

  • Lot #: 19286
  • Exp. Date:01/21

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.

See all 19 products in this recall →

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