Recalls / Class II
Class IID-0771-2022
Product
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
- Affected lot / code info
- Lot #: A1122P, G1421N, Exp. 1/1/2023
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.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, N/A, Anaheim, California 92807-1801
Distribution
- Quantity
- 41 Tubes
- Distribution pattern
- Product distributed in California and Florida.
Timeline
- Recall initiated
- 2022-03-24
- FDA classified
- 2022-04-14
- Posted by FDA
- 2022-04-20
- Terminated
- 2023-11-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0771-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.