The Recall Desk
ModerateFDA (Drugs)·D-0011-2021·Announced 2020-10-14

Calvin Scott Recalls Phentermine Capsules Due to Stability Study Deviations

Calvin Scott & Company is recalling specific lots of Phentermine 30 mg capsules because they were repackaged without supporting stability studies.

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, which corresponds to a moderate severity score under the rubric for minor labeling or process errors without reported illness.

Plain-English summary

Calvin Scott & Company, Inc. is voluntarily recalling specific lots of Phentermine 30 mg capsules. The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations where the drug products were repackaged into pouches without supporting stability studies.

The affected product is identified by NDC 00527-0597-10 and includes Lot numbers CS19309 and CS20098, with an expiration date of 12/21. The products were distributed to 12 physician consignees located in California, Idaho, Illinois, Oklahoma, and Rhode Island.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
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 (3)

  • Lot #: CS19309
  • CS20098
  • Exp 12/21

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

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