The Recall Desk
ModerateFDA (Drugs)·D-1521-2020·Announced 2020-08-26

Calvin Scott Recalls Phendimetrazine Tablets Due to Packaging Defects

Calvin Scott & Company is recalling specific lots of Phendimetrazine 35mg tablets because they were repackaged in transparent pouches, violating CGMP requirements for light-sensitive drugs.

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 for light-sensitive drugs, which fits the criteria for moderate severity involving minor labeling or packaging errors without reported illness.

Plain-English summary

Calvin Scott & Company, Inc. is voluntarily recalling specific lots of Phendimetrazine Yellow Tabs 35mg, 28-count bags. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where light-sensitive drug products were repackaged in transparent or partially transparent pouches.

The affected product is distributed nationwide within the United States. Specific lot numbers and expiration dates are listed in the recall documentation, including lots 19185, 19220, 19256, 19334, 20001, and 20046.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on return or replacement.

The recalled product

Product
Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech, Newtown, PA 18940, NDC 0702-0077-10
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 (10)

  • Lot #: 19185
  • 19220
  • Exp. Date: 08/20
  • 19256
  • Exp. Date: 09/20
  • 19334
  • Exp. Date: 12/20
  • 20001
  • Exp. Date: 01/21: 20046
  • 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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