The Recall Desk
ModerateFDA (Drugs)·D-0009-2021·Announced 2020-10-14

Calvin Scott Recalls Diethylpropion Tablets Due to Stability Deviations

Calvin Scott & Company is recalling specific lots of Diethylpropion 25 mg tablets 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 due to a cGMP deviation (lack of stability studies) without reported illnesses or injuries, fitting the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Calvin Scott & Company, Inc. is voluntarily recalling specific lots of Diethylpropion, 25 mg tablets, NDC 00527-1475-01. The recall was initiated because the drug products were repackaged into pouches without supporting stability studies, which constitutes a Current Good Manufacturing Practice (cGMP) deviation.

The affected products were distributed to 12 physician consignees located in California, Idaho, Illinois, Oklahoma, and Rhode Island. The recall includes lots CS19311, CS19337, CS20018B, CS20019, CS20037, CS20075, CS20076, CS20112, CS20169, CS20168, CS20199, and CS20243, with expiration dates ranging from December 2020 to July 2022.

Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
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 (17)

  • Lot #: CS19311
  • CS19337
  • Exp 12/20
  • CS20018B
  • CS20019
  • CS20037
  • CS20075
  • CS20076
  • CS20112
  • CS20169
  • Exp 8/21
  • CS20168
  • Exp 12/21
  • CS20199
  • Exp 5/22
  • CS20243
  • Exp 7/22

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 →

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