Recalls / Class II
Class IID-0751-2021
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.
- Affected lot / code info
- Lot # 16630; Exp 03/2023
Why it was recalled
Correct Labeled Product Mispack
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- 14688 tubes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-07-19
- FDA classified
- 2021-08-18
- Posted by FDA
- 2021-08-25
- Terminated
- 2024-08-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0751-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.