The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1531-2020·Announced 2020-08-26

Calvin Scott Recalls Phentermine Tablets Due to Packaging Deviations

Calvin Scott & Company is recalling specific lots of Phentermine HCL tablets because they were repackaged in transparent pouches, violating CGMP requirements for light-sensitive drugs.

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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a packaging deviation (CGMP) rather than a direct contamination or mislabeling of the active ingredient.

Plain-English summary

Calvin Scott & Company, Inc. is recalling specific lots of Phentermine HCL White/Blue Speckled tablets, 37.5 mg. The affected product is packaged in 7-count and 28-count bags and is distributed nationwide within the United States. The specific lot number is 19350, with an expiration date of 1/21.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. The source text indicates that the light-sensitive drug products were repackaged in transparent or partially transparent pouches, which is a violation of standard packaging requirements for such medications.

Consumers and healthcare providers should check their inventory for the specific NDC 00527-1445-10 and Lot # 19350. If the product matches these details, it should be returned to the pharmacy or distributor for replacement or refund.

The recalled product

Product
Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count bags, and b) 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Lannett Company, Inc. Philadelphia, PA 19136; NDC 00527-1445-10
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 # a) and b) 19350
  • 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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