Recalls / Class II
Class IID-0083-2019
Product
HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.
- Brand name
- Hydroxyzine Hydrochloride
- Generic name
- Hydroxyzine Hydrochloride
- Active ingredient
- Hydroxyzine Dihydrochloride
- Route
- Oral
- NDC
- 54838-502
- FDA application
- ANDA201674
- Affected lot / code info
- Lot #: 1097, Exp 10/18
Why it was recalled
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Recalling firm
- Firm
- Lannett Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9000 State Rd, N/A, Philadelphia, Pennsylvania 19136-1615
Distribution
- Quantity
- 8,324 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-10-11
- FDA classified
- 2018-10-19
- Posted by FDA
- 2018-10-31
- Terminated
- 2019-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0083-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.