FDA Recalls Vital Care Compounder Injection Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling C-PAP/PHEN/PROST/Atrop 150/7.5 injection vials 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization reports are rated as Severe (4). While specific injury reports are not detailed in the provided text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious adverse health consequences, aligning with the Severe classification for Class II recalls with potential for significant harm.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection) manufactured by Pharmacy Plus, Inc. dba Vital Care Compounder in Hattiesburg, Mississippi. The recall is being conducted because the product lacks assurance of sterility.
The affected product consists of 10 ml vials containing 5.9 ml of solution. The specific lot number is 397877, with a use-by date of January 6, 2017. The distribution pattern is listed as Mississippi (MS).
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable Compound
- Affected units
- 1
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 (2)
- Lot# 397877
- USE BY 1-6-17
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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