Econazole Nitrate Cream Recalled Due to Manufacturing Practice Deviations
Preferred Pharmaceuticals is recalling Econazole Nitrate Cream 1% due to CGMP deviations. The manufacturer discontinued its stability study program; affected lots were distributed in California and Florida.
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 due to CGMP deviations with no reported illnesses or adverse events. The hazard is theoretical, related to loss of manufacturing oversight rather than confirmed product defect.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Econazole Nitrate Cream 1% (generic for Spectazole) supplied in 30-gram tubes. The affected product was distributed in California and Florida. Lot numbers A1122P and G1421N are included in this recall, with an expiration date of January 1, 2023.
The recall was initiated because the manufacturing firm, Teligent Pharma, Inc., is discontinuing its stability study program. All products within their expiration date are affected. The discontinuation of stability testing represents a deviation from Current Good Manufacturing Practice (CGMP) requirements, which mandate ongoing monitoring to ensure drugs maintain their safety and effectiveness throughout their shelf life.
The recalled product
- Product
- Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Topical Antifungal
- Affected units
- 41
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 (3)
- Lot #: A1122P
- G1421N
- Exp. 1/1/2023
Distribution
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