The Recall Desk
ModerateFDA (Drugs)·D-1523-2020·Announced 2020-08-26

Calvin Scott Recalls Phendimetrazine Capsules Due to Packaging Deviation

Calvin Scott & Co. is recalling specific lots of Phendimetrazine 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 for light-sensitive drugs. It fits the 'Moderate' criteria as a voluntary precautionary recall with no reported illnesses or injuries.

Plain-English summary

Calvin Scott & Company, Inc. is recalling specific lots of Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags. The product is prescription-only and was distributed nationwide within the United States. The recall involves lots 19169, 19237, 19331, and 20031, with expiration dates ranging from July 2020 to March 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 regulatory standards for protecting light-sensitive medications.

Consumers and healthcare providers with these specific lots should stop using the product and contact their pharmacist or the recalling firm for instructions on disposal or replacement. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11
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 (12)

  • Lot #: 19169
  • Exp. Date: 7/20
  • 08/20
  • 09/20
  • 19237
  • Exp. Date: 10/20
  • 11/20
  • 12/20
  • 19331
  • Exp. Date: 12/20
  • 20031
  • Exp. Date: 3/21

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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