The Recall Desk
LowFDA (Drugs)·D-1440-2014·Announced 2014-07-23

Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

Fougera Pharmaceuticals is recalling specific lots of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Fougera Pharmaceuticals Inc. is recalling 111,388 bottles of Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL. The affected product is a prescription-only dermatologic lotion manufactured by E. Fougera & Co, a division of Fougera Pharmaceuticals Inc., located in Melville, New York. The recall covers lots 497R, 498R, 635R, 636R, 850R, 073S, and 074S, with expiration dates ranging from January 2015 to June 2015.

The recall was initiated because it has been determined that the pH of the recalled lots may not meet specification at expiry. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should discontinue use of the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. The product was distributed nationwide.

The recalled product

Product
Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
Manufacturer
Fougera Pharmaceuticals Inc.
Category
Drug — Topical Steroid
Hazard
Affected units
111,388

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 (12)

  • Lot(s): 497R
  • 498R
  • Exp 01/2015
  • 635R
  • 636R
  • Exp 03/2015
  • 850R
  • Exp 04/2015
  • 073S
  • Exp 05/2015
  • 074S
  • Exp 06/2015.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Fougera Pharmaceuticals 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 2 products in this recall →

Related recalls

Same manufacturer · Fougera Pharmaceuticals Inc.

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Same hazard · ph specification

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