The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0700-2022·Announced 2022-03-30

Clobetasol Propionate Cream USP Recalled for cGMP Deviations

Teligent Pharma, Inc. is recalling Clobetasol Propionate Cream USP 0.05% in 60-gram tubes due to current Good Manufacturing Practice (cGMP) deviations. The firm discontinued its stability study program, affecting all products within expiry nationwide and in Puerto Rico.

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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard stems from manufacturing practice deviations and discontinuation of stability testing rather than confirmed product contamination or defect. The recall is precautionary in nature.

Plain-English summary

Teligent Pharma, Inc. is recalling Clobetasol Propionate Cream USP, 0.05%, packaged in 60-gram tubes (NDC 70512-028-60), manufactured for SOLA Pharmaceuticals in Baton Rouge, Louisiana. The recall involves 26,326 tubes with batch numbers 16001 (expiring 9/30/2022) and 16089 (expiring 11/30/2022).

The recall is due to cGMP deviations. The firm has discontinued its stability study program, and all products within their expiry dates are being recalled as a result. The product is distributed nationwide in the United States and Puerto Rico.

Patients using this medication should consult with their healthcare provider or pharmacist before discontinuing use or switching to an alternative treatment. Healthcare providers and patients with questions about this recall should contact the manufacturer or the FDA.

The recalled product

Product
Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
26,326

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 (2)

  • Batch: 16001 Exp. 9/30/2022
  • 16089 Exp. 11/30/2022

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 37 recalled by Teligent Pharma, 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 37 products in this recall →

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