The Recall Desk
ModerateFDA (Drugs)·D-0751-2021·Announced 2021-08-25

Econazole Nitrate Cream 1% recalled due to labeling mispack

Teligent Pharma is recalling Econazole Nitrate Cream 1% in 85-gram bulk tubes due to incorrect labeling. The product was distributed nationwide.

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: This is an FDA Class II recall involving a labeling error with no reported illnesses or injuries. The hazard is administrative (labeling mispack) rather than safety-related, placing it in the moderate category for minor labeling issues per the rubric.

Plain-English summary

Teligent Pharma, Inc. is recalling Econazole Nitrate Cream 1% in 85-gram bulk shipper tubes (NDC 52565-022-85) due to a labeling mispack issue. The recalled product was distributed nationwide.

The specific lot affected is Lot # 16630 with an expiration date of 03/2023. A total of 14,688 tubes have been recalled. The product is a prescription-only medication manufactured by Teligent Pharma, Inc. in Buena, New Jersey.

Patients and healthcare providers who have this product should contact Teligent Pharma, Inc. for instructions on the recalled medication.

The recalled product

Product
Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Antifungal
Hazard
  • labeling-error
  • mispack

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)

  • Lot # 16630
  • Exp 03/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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