Why it was recalled
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: A1122P, G1421N, Exp. 1/1/2023
Where it was sold
Product distributed in California and Florida.
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-0771-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 24, 2022
- FDA report date
- Apr 20, 2022
- Quantity
- 41 Tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0771-2022, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 89943
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot #: A1122P, G1421N, Exp. 1/1/2023
- Postal code
- 92807-1801
- Report date
- Apr 20, 2022
- Product type
- Drugs
- Recall number
- D-0771-2022
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- 41 Tubes
- Termination date
- Nov 17, 2023
- Reason for recall
- CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product distributed in California and Florida.
- Recall initiation date
- Mar 24, 2022
- Initial firm notification
- Center classification date
- Apr 14, 2022