The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1522-2020·Announced 2020-08-26

Calvin Scott Recalls Phendimetrazine Tablets Due to Packaging Deviation

Calvin Scott & Company is recalling specific lots of Phendimetrazine 35mg tablets because light-sensitive products were repackaged in transparent pouches.

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 packaging deviation (light sensitivity) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Calvin Scott & Company, Inc. is recalling specific lots of Phendimetrazine Yellow Tabs 35mg. The product is distributed in 10-count, 28-count, and 56-count bags and is manufactured by Virtus Pharm, LLC. The recall covers lots with expiration dates ranging from 09/20 to 02/21.

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 may not provide adequate protection from light.

Consumers and healthcare providers should stop using the affected products and return them to the pharmacy or point of purchase. The affected NDC is 69543-0410-11.

The recalled product

Product
Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.
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 (13)

  • a) Lot #: 19236
  • Exp. Date 10/20 b) Lot #: 19170
  • 19236
  • Exp. Date: 09/20
  • 19303
  • Exp. Date: 11/20
  • 19347
  • Exp. Date: 12/20
  • 19353
  • Exp. Date: 01/21: 20032
  • 20047
  • Exp. Date: 2/21. c) Lot #: 19236
  • Exp. Date 10/20

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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