Agency classClass IIOur severity:Severe FDA (Drugs)·D-1535-2016·Announced 2016-10-05

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.

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, 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
Hazard: sterility
infection

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.

See all 21 products in this recall →

Same manufacturer · Pharmacy Plus, Inc. dba Vital Care Compounder

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