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.
What this means for you
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
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:
- IL
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