Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Product description
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.
Lot numbers, UPCs & expiration codes
Batch: a) 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; b) 15349, Exp. 2/28/2022; 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; c) 16410, 16438, Exp. 1/31/2023
Where it was sold
Nationwide in the USA and Puerto Rico
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-0682-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 15, 2022
- FDA report date
- Mar 30, 2022
- Quantity
- 151,975 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0682-2022, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89798
- Address
- 105 Lincoln Avenue
- Code information
- Batch: a) 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; b) 15349, Exp. 2/28/2022; 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; c) 16410, 16438, Exp. 1/31/2023
- Postal code
- 08310
- Report date
- Mar 30, 2022
- Product type
- Drugs
- Recall number
- D-0682-2022
- Classification
- Class II
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 151,975 tubes
- Termination date
- Jun 17, 2024
- Reason for recall
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Mar 15, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2022