D-0083-2019 Class II Terminated
FDA drug recall D-0083-2019 was initiated by Lannett Company, Inc. on October 11, 2018 and is designated Class II. Reason for recall: CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities. The recall status is terminated (terminated February 22, 2019). Affected quantity: 8,324 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 31, 2018
- Initiation Date
- October 11, 2018
- Termination Date
- February 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,324 bottles
Product Description
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.
Reason for Recall
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1097, Exp 10/18