The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1517-2020·Announced 2020-08-26

Calvin Scott Recalls Thyroid 1 Grain Tablets Due to Packaging Defects

Calvin Scott & Co. is recalling specific lots of Thyroid 1 Grain 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 the hazard involves a CGMP deviation regarding packaging that could compromise drug stability, fitting the criteria for moderate severity without reported injuries.

Plain-English summary

Calvin Scott & Company, Inc. is recalling Thyroid 1 Grain Tablets, 28-count bags, due to Current Good Manufacturing Practice (CGMP) deviations. The affected product is distributed by Calvin Scott & Co., Inc. in Albuquerque, NM, and manufactured by RLC Labs in Cave Creek, AZ. The specific NDC is 64727-3300-02.

The recall was initiated because light-sensitive drug products were repackaged in transparent or partially transparent pouches. This packaging choice deviates from CGMP requirements for protecting light-sensitive medications. The affected lots include Lot #19233 (Exp. 08/20), Lot #19254 (Exp. 09/20), and Lot #19273 (Exp. 1/21). The product was distributed nationwide within the United States.

Consumers should check their medication for the specific lot numbers and expiration dates listed above. If you possess the recalled product, you should stop using it and contact your pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

Product
Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs, Cave Creek, AZ 85331, NDC 64727-3300-02
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 (6)

  • Lot #: 19233
  • Exp. Date: 08/20
  • 19254
  • Exp. Date 09/20
  • 19273
  • Exp. Date: 1/21

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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