Recalls / Class II
Class IID-0768-2022
Product
Clobetasol Propionate Lotion 0.05%, Generic for Temovate, 118 mL bottle, Rx Only, Mfg: Teligent Pharma, Inc., PREFERRED Pharmaceuticals, Inc., The Physician's Solution, NDC 68788-7768-01
- Affected lot / code info
- Lot #: A0721O, A1421Y, A2121G, A2821D, B0421H, B0421I, B0521U, B1121G, B1921C, C0421B, C1821N, L0120F, L2320O, L3020T, Exp.: 4/30/2022; B2521A, C1121S, C2521U, D0121S, D0921B, D1421B, D2921C, E0721A, Exp.: 10/31/2022; D2221A, Exp.: 12/31/2022
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
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, N/A, Anaheim, California 92807-1801
Distribution
- Quantity
- 1568 bottles
- Distribution pattern
- IL
Timeline
- Recall initiated
- 2022-03-23
- FDA classified
- 2022-04-14
- Posted by FDA
- 2022-04-20
- Terminated
- 2023-05-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0768-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.