Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
Lot numbers, UPCs & expiration codes
Lot# 620984, 620987, Exp 04/2015; 621481, 621484, 621752, 621754 Exp 05/2015; 621875, 622239 Exp 06/2015; 622742, 622745, 623371 Exp 08/2015; 623374, 623820, 623823 Exp 09/2015; 624265, 624268 Exp 10/2015; 624824, 624827 Exp 11/2015; 625472, 625475 Exp 01/2016; 625783, 625786, 626447, 626450 02/2016; 627683, 627797 Exp 05/2016; 627800 Exp 06/2016; 629094, 629097, 629100, 629103 Exp 08/2016; 629928 Exp 09/2016; 629931, 630480, 630483 Exp 10/2016; 630874, 630877, 631513 Exp 12/2016
Where it was sold
Nationwide including Puerto Rico
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-1130-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 7, 2015
- FDA report date
- Jun 17, 2015
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-1130-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71033
- Address
- 1925 W. Field Court, Suite 300
- Code information
- Lot# 620984, 620987, Exp 04/2015; 621481, 621484, 621752, 621754 Exp 05/2015; 621875, 622239 Exp 06/2015; 622742, 622745, 623371 Exp 08/2015; 623374, 623820, 623823 Exp 09/2015; 624265, 624268 Exp 10/2015; 624824, 624827 Exp 11/2015; 625472, 625475 Exp 01/2016; 625783, 625786, 626447, 626450 02/2016; 627683, 627797 Exp 05/2016; 627800 Exp 06/2016; 629094, 629097, 629100, 629103 Exp 08/2016; 629928 Exp 09/2016; 629931, 630480, 630483 Exp 10/2016; 630874, 630877, 631513 Exp 12/2016
- Postal code
- 60045
- Report date
- Jun 17, 2015
- Product type
- Drugs
- Recall number
- D-1130-2015
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Termination date
- Nov 29, 2017
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16
- Distribution pattern
- Nationwide including Puerto Rico
- Recall initiation date
- Apr 7, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 9, 2015