FDA Recalls Vital Care Compounder Injection Due to Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling C-PAP/PHEN/PROST/ATROP 150/5/5 injection vials due to a lack of assurance of sterility.
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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with a lack of sterility assurance in an injectable drug.
Plain-English summary
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection) vials. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product consists of 10 ml vials containing 5.8 ml of solution. The specific lot number is 397877, with a use-by date of 1-6-17. The product was distributed in Mississippi.
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
- C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Injectable
- Hazard
- 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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