The Recall Desk
ModerateFDA (Drugs)·D-0682-2022·Announced 2022-03-30

Econazole Nitrate Cream Recalled Due to Manufacturing Process Deviations

Teligent Pharma is recalling Econazole Nitrate Cream, 1% due to current Good Manufacturing Practice deviations related to discontinued stability studies. Approximately 151,975 tubes distributed nationwide are affected.

What this means for you

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: FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory—discontinued stability studies creating uncertain product stability—not a confirmed contamination or defect. This falls within the low-risk, precautionary recall category.

Plain-English summary

Teligent Pharma, Inc. is recalling all lots of Econazole Nitrate Cream, 1% within their expiration dates due to current Good Manufacturing Practice (cGMP) deviations. The recall was initiated because the manufacturer discontinued its stability study program.

Econazole Nitrate Cream is a prescription antifungal medication supplied in three package sizes: 15-gram tubes (NDC 52565-022-15), 30-gram tubes (NDC 52565-022-30), and 85-gram tubes (NDC 52565-022-85). Approximately 151,975 tubes have been distributed nationwide in the United States and Puerto Rico.

The affected product includes batches with the following lot numbers and expiration dates: 16410, 16438 (expires 1/31/2023); 16882 (expires 4/30/2023); and 15349 (expires 2/28/2022). Patients should contact their healthcare provider or pharmacist for guidance regarding their current prescriptions.

The recalled product

Product
Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Antifungal
Hazard
Affected units
151,975

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 (9)

  • Batch: a) 16410
  • 16438
  • Exp. 1/31/2023
  • 16882
  • Exp. 4/30/2023
  • b) 15349
  • Exp. 2/28/2022
  • 16410
  • c) 16410

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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