The Recall Desk
ModerateFDA (Drugs)·D-1525-2020·Announced 2020-08-26

Calvin Scott Recalls Phentermine 15mg Capsules Due to Packaging Defect

Calvin Scott & Company is recalling Phentermine 15mg capsules because light-sensitive products 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 and 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 Phentermine 15mg grey/Yellow Capsules, 28-count bags. The product is distributed nationwide within the United States. The specific lot affected is Lot #19330 with an expiration date of 12/20.

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 standards for protecting the medication from light.

Consumers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on disposal or replacement. The product is prescription-only, so patients should consult their prescriber regarding next steps.

The recalled product

Product
Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Sunrise Pharm., Rahway NJ, 07065; NDC 11534-0157-03
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 #:19330
  • Exp. Date: 12/20

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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