Why it was recalled
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Product description
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Lot numbers, UPCs & expiration codes
Lot#: a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.
Where it was sold
Nationwide USA and 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-0174-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 9, 2020
- FDA report date
- Dec 30, 2020
- Quantity
- 127,392 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0174-2021, exactly as published.
Show all FDA fields
- City
- Morton Grove
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 86904
- Address
- 6451 Main St
- Code information
- Lot#: a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.
- Postal code
- 60053-2633
- Report date
- Dec 30, 2020
- Product type
- Drugs
- Recall number
- D-0174-2021
- Classification
- Class II
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Product quantity
- 127,392 bottles
- Termination date
- Sep 24, 2022
- Reason for recall
- Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Dec 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 23, 2020