Agency classClass IIOur severity:High FDA (Drugs)·D-0768-2022·Announced 2022-04-20

Clobetasol Propionate Lotion Recalled Due to Manufacturing Deviations

Preferred Pharmaceuticals is recalling Clobetasol Propionate Lotion 0.05% distributed in Illinois due to manufacturing deviations and discontinued stability study program. Consumers should contact their healthcare provider.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—discontinued stability study program prevents future quality assurance of unexpired product. Per the rubric, risk-of-harm products without reported injury merit a High severity rating.

Plain-English summary

Clobetasol Propionate Lotion 0.05%, a topical corticosteroid medication available by prescription only, is being recalled. The affected product consists of 1,568 bottles of 118 mL size, manufactured by Teligent Pharma, Inc. and distributed by Preferred Pharmaceuticals, Inc. and The Physician's Solution. The product has NDC 68788-7768-01 and is a generic equivalent of Temovate.

The recall is due to current Good Manufacturing Practice (CGMP) deviations. The manufacturing firm is discontinuing its stability study program. All products within their expiration dates are subject to this recall.

The affected product was distributed in Illinois. Consumers who have this medication should contact their pharmacy or healthcare provider for guidance.

The recalled product

Product: Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01
Manufacturer: Preferred Pharmaceuticals, Inc.
Category: Drug — Topical corticosteroid
Hazard: manufacturing-deviation
Affected units: 1,568

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 (20)

Lot #: A0721O
A1421Y
A2121G
A2821D
B0421H
B0421I
B0521U
B1121G
B1921C
C0421B
C1821N
L0120F
L2320O
L3020T
Exp.: 4/30/2022
B2521A
C1121S
C2521U
D0121S
D0921B

Distribution

Distributed in 1 state:

Same manufacturer · Preferred Pharmaceuticals, Inc.

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