The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0010-2021·Announced 2020-10-14

Calvin Scott Recalls Diethylpropion Tablets Due to Missing Stability Studies

Calvin Scott & Company is recalling specific lots of Diethylpropion 75 mg tablets because they were repackaged without supporting stability studies.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a cMGP deviation (missing stability studies) which is a quality control issue rather than a direct, reported physical hazard like a high-risk pathogen or structural defect.

Plain-English summary

Calvin Scott & Company, Inc. is recalling specific lots of Diethylpropion 75 mg tablets, NDC 00527-1477-01. The recall was initiated because the drug products were repackaged into pouches without supporting stability studies. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products were distributed to 12 physician consignees located in California, Idaho, Illinois, Oklahoma, and Rhode Island. The specific lot numbers involved are CS19192, CS19226, CS19263 (Exp 10/20), CS19300 (Exp 7/21), CS19338 (Exp 8/21), CS20034 (Exp 10/21), CS20077 (Exp 1/22), CS20165, and CS20241 (Exp 4/22).

Physicians and healthcare providers should stop using the affected lots and contact Calvin Scott & Company for further instructions. Patients who have received these specific lots should consult their healthcare provider regarding the recall.

The recalled product

Product
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
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 (15)

  • Lot #: CS19192
  • CS19226
  • CS19263
  • Exp 10/20
  • CS19300
  • Exp 7/21
  • CS19338
  • Exp 8/21
  • CS20034
  • Exp 10/21
  • CS20077
  • Exp 1/22
  • CS20165
  • CS20241
  • Exp 4/22

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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