Why it was recalled
Correct Labeled Product Mispack
Product description
Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
Lot numbers, UPCs & expiration codes
Lot # 16630; Exp 03/2023
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0751-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 19, 2021
- FDA report date
- Aug 25, 2021
- Quantity
- 14688 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0751-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88293
- Address
- 105 Lincoln Avenue
- Code information
- Lot # 16630; Exp 03/2023
- Postal code
- 08310
- Report date
- Aug 25, 2021
- Product type
- Drugs
- Recall number
- D-0751-2021
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 14688 tubes
- Termination date
- Aug 16, 2024
- Reason for recall
- Correct Labeled Product Mispack
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2021