FDA Recalls Hydroxyzine HCl Injection Due to Sterility Concerns
Pharmacy Plus, Inc. is recalling 139 vials of Hydroxyzine HCl injection in Mississippi due to a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility issues in injectable medications which carry significant risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Hydroxyzine HCl, 50mg/ml Injection, 10ml Multi-Dose Vials (MDV) manufactured by Pharmacy Plus, Inc. dba Vital Care Compounder in Hattiesburg, Mississippi. The recall involves 139 vials distributed within Mississippi. The affected products include Lot #365204 with a use-by date of 8/1/16 and Lot #384395 with a use-by date of 3/12/17.
The recall was initiated due to a lack of assurance of sterility. This classification indicates that use of the product could cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote.
Consumers and healthcare providers in Mississippi who have these specific lots of Hydroxyzine HCl injection should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable
- Hazard
- Affected units
- 139
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 (3)
- Lot #: 365204
- Use by 8/1/16 and 384395
- Use by 3/12/17
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 21 recalled by Pharmacy Plus, Inc. dba Vital Care Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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