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
- stability-unverified
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.
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