The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0703-2022·Announced 2022-03-30

Hydrocortisone Butyrate Lotion Recalled for cGMP Deviations

Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% due to current Good Manufacturing Practice (cGMP) deviations related to the firm's discontinuation of its stability study program.

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 involving a manufacturing practice deviation. The source text contains no reports of illness, injury, or product failure; the hazard is procedural and precautionary in nature rather than acute. Per the rubric, Class II recalls without reported adverse events typically fall in the Moderate range.

Plain-English summary

Teligent Pharma, Inc. is recalling all unexpired Hydrocortisone Butyrate Lotion, 0.1%, in 4 fl oz (118 mL) bottles (NDC 70512-032-04), manufactured for SOLA Pharmaceuticals. The recall includes batches 16896 and 16897, with an expiration date of 5/31/2023. Approximately 6874 bottles are affected.

The recall is being conducted because the firm is discontinuing its stability study program, which constitutes a deviation from current Good Manufacturing Practice (cGMP) standards. This results in a lack of adequate data to support the continued distribution of the product.

The affected product has been distributed nationwide in the United States and Puerto Rico. This is a prescription-only medication. Patients currently using this product should contact their healthcare provider for guidance before discontinuing use.

The recalled product

Product
Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
6,874

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: 16896
  • 16897 Exp. 5/31/2023

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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