Recalls / Class II
Class IID-0096-2021
Product
Salicylic Acid Shampoo 3%, Bulk Product, 360 Therapeutics
- Affected lot / code info
- Lot #: HV349
Why it was recalled
GMP Deviations
Recalling firm
- Firm
- Milbar Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 20 Commerce St, N/A, East Haven, Connecticut 06512-4145
Distribution
- Quantity
- 198.8 kg
- Distribution pattern
- Product was distributed throughout the United States, including Puerto Rico and internationally.
Timeline
- Recall initiated
- 2020-10-09
- FDA classified
- 2020-11-17
- Posted by FDA
- 2020-11-25
- Terminated
- 2023-01-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0096-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.