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.
Reported: October 31, 2018 Initiated: October 11, 2018 #D-0083-2019
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.
Details
- Recalling Firm
- Lannett Company, Inc.
- Units Affected
- 8,324 bottles
- Distribution
- Nationwide in the USA
- Location
- Philadelphia, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lannett Company, Inc.. Units affected: 8,324 bottles.
Why was this product recalled? ▼
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0083-2019.
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