The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1532-2020·Announced 2020-08-26

Calvin Scott Recalls Phentermine Tablets Due to Packaging Defect

Calvin Scott & Company is recalling specific lots of Phentermine HCL 37.5 mg tablets because they were repackaged in transparent pouches, violating light-sensitivity requirements.

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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a packaging defect (light sensitivity) rather than a direct contamination or mislabeling of an allergen, fitting the Moderate severity criteria for minor labeling/packaging errors or low-risk contamination.

Plain-English summary

Calvin Scott & Company, Inc. is recalling specific lots of Phentermine HCL Blue Speckled tablets, 37.5 mg. The affected products are packaged in 14-count and 28-count bags and are distributed nationwide within the United States. The recall involves multiple lot numbers with expiration dates ranging from August 2020 to February 2021.

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 the required packaging standards for light-sensitive medications.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for disposal or replacement. No specific adverse health events are reported in the source text.

The recalled product

Product
Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags (NDC 10702-0025-10) and b) 28-count bags (NDC 10702-0025-10), Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech., Inc Newtown, PA 18940.
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 (18)

  • Lot #: a) 19271
  • Exp. Date 10/20 b) 19206
  • 19209B
  • Exp. Date 08/20
  • 19229
  • Exp. Date 10/20
  • 19255
  • Exp. Date 09/20
  • 19271
  • 19301
  • 19327
  • Exp. Date 11/20
  • 19336
  • Exp. 12/20
  • 20012
  • Exp. Date 1/21
  • 20045
  • Exp. Date 2/21.

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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