Vital Care Compounder Recalls Chlorpheniramine Maleate Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 108 vials of Chlorpheniramine Maleate 10 mg/ml due to 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 explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), as it indicates a potential for temporary or medically reversible adverse health consequences.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 108 vials of Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, prescription (Rx) medication. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is distributed in Mississippi (MS). Specific lot numbers 373003 and 381408 are involved, with a use-by date of 02-11-17. The product was manufactured by Vital Care Compounder in Hattiesburg, MS.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Pharmaceutical
- Hazard
- Affected units
- 108
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# 373003
- 381408
- Use by 02-11-17
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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