Reported Dec 30, 2020 · Terminated
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC…
Morton Grove Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Morton Grove Pharmaceuticals, Inc. · 6451 Main St · Morton Grove, IL · 60053-2633
Is this the product you have?
Hydroxyzine Hydrochloride Oral SolutionUSP (Syrup)10 mg/5 mLpackaged in a) 4 fl oz (118 mL) bottleNDC 60432-150-04b) 1 pint (473 mL)NDC 60432-150-16Rx Only
- Manufactured ByMorton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
- Lot codes and dates
Lot#: a) UU1328Exp 10/21b) UU1207Exp 07/21UU1326Exp 09/21UU1327Exp 10/21
- Amount recalled
- 127,392 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
This product could cause temporary or reversible health problems — stop using it.
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