Why it was recalled
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
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.
Lot numbers, UPCs & expiration codes
Lot #: 1097, Exp 10/18
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0083-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 11, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 8,324 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company, Inc.
Original FDA data
Every field from FDA enforcement report D-0083-2019, exactly as published.
Show all FDA fields
- City
- Philadelphia
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 81225
- Address
- 9000 State Rd
- Code information
- Lot #: 1097, Exp 10/18
- Postal code
- 19136-1615
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0083-2019
- Classification
- Class II
- Recalling firm
- Lannett Company, Inc.
- Product quantity
- 8,324 bottles
- Termination date
- Feb 22, 2019
- Reason for recall
- CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 11, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 19, 2018