FDA Recalls Vital Care Compounder Papaverine and Prostaglandin Vials for Sterility Concerns
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling specific lots of Papaverine and Prostaglandin 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical product, which aligns with the rubric for Severe severity (FDA Class II with potential for significant injury).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg vials manufactured by Pharmacy Plus, Inc. dba Vital Care Compounder. The recall is due to a lack of assurance of sterility in the product.
The affected product is packaged as 5.5 mL in a 10 mL MDV and is prescription-only. The specific lots subject to the recall are 386606 (Use by 8-9-16) and 393302 (Use by 10-28-16). The distribution pattern is listed as MS (Mississippi).
Consumers and healthcare providers should check their inventory for these specific lot numbers and dates. If the product is found, it should be returned to the pharmacy or manufacturer for disposal or credit, as directed by the recalling firm.
The recalled product
- Product
- Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
- Manufacturer
- Pharmacy Plus, Inc. dba Vital Care Compounder
- Category
- Drug — Compounded Medication
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 (4)
- Lot#: 386606
- Use by 8-9-16
- 393302
- Use by 10-28-16
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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