Vital Care Compounder Recalls Papaverine and Phentolamine Vials Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Papaverine 150 mg / Phentolamine 5 mg 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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While specific injury reports are not detailed in the text, the Class II designation for a sterile injection product involving sterility assurance issues aligns with the Severe criteria for significant risk.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 3 vials of Papaverine 150 mg / Phentolamine 5 mg sterile injection. The product is packaged in a sterile, clear 10 mL MDV and is available by prescription only. The recall is limited to Lot# 386184 with a use-by date of 08-03-16.
The recall was initiated due to a lack of assurance of sterility. The affected products were distributed in Mississippi (MS).
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Sterile Injection
- Hazard
- Affected units
- 3
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# 386184
- Use by 08-03-16
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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