Hi-Tech Pharmacal Recalls HydrOXYzine Hydrochloride Oral Solution Due to Impurity
Hi-Tech Pharmacal Co., Inc. is recalling 451,916 bottles of HydrOXYzine Hydrochloride Oral Solution because an unknown impurity exceeded specifications during stability testing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they are reasonably likely to cause temporary or medically reversible adverse health consequences.
Plain-English summary
Hi-Tech Pharmacal Co., Inc. is recalling 451,916 bottles of HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL. The product is available under NDC 50383-796-16 and NDC 10702-052-16. The recall covers batches with expiration dates ranging from April 2014 to February 2016.
The recall was initiated because the product failed an impurity/degradation specification. Specifically, an out-of-specification result was found for one individual unknown impurity at the 24-month room temperature stability test station. The agency has classified this recall as Class II.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific batch numbers listed in the recall notice and stop using the product if it matches the recalled lots.
The recalled product
- Product
- HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702
- Manufacturer
- Hi-Tech Pharmacal Co., Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 451,916
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Batch 609442 (exp. 4/2014)
- 609445 (exp. 4/2014)
- Batch 609919 (exp. 4/2014)
- Batch 609964 (exp. 5/2014)
- Batch 609966 (exp. 5/2014)
- Batch 610204 (exp. 5/2014)
- Batch 610406 (exp. 5/2014)
- Batch 610572 (exp. 6/2014)
- Batch 610575 (exp. 6/2014)
- Batch 610677 (exp. 6/2014)
- Batch 610808 (exp. 6/2014)
- Batch 611110 (exp. 7/2014)
- Batch 611201 (exp. 8/2014)
- Batch 611530 (exp. 8/2014)
- Batch 611645 (exp.9/2014)
- Batch 611891 (exp. 9/2014)
- Batch 611993 (exp. 10/2014)
- Batch 612328 (exp. 11/2014)
- Batch 612331 (exp. 11/2014)
- Batch No. 613050 (exp. 12/2014)
Distribution
Distributed nationwide across the United States.
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