The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1090-2018·Announced 2018-08-22

Ranier's P/P/P Injection Recalled for Sterility Assurance Concerns

Ranier's Compounding Laboratory is recalling P/P/P Injection vials because practices at the firm may call into question the sterility of the products.

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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance issues for injectable products.

Plain-English summary

Ranier's Compounding Laboratory is recalling P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vials. The recall was initiated due to a lack of assurance of sterility, as practices at the firm may call into question the sterility of products intended to be sterile.

The affected product is prescription-only and was distributed within the state of Pennsylvania. The recall covers all lots within expiry.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
P/P/P (Prostaglandin/Papaverine/Phentolamine) Injection, 0.02/30/2 mg/mL, 5 mL vial, Rx only, Ranier's Rx Laboratory, 1107 Lowry Avenue Suite A, Jeannette, PA 15644.
Manufacturer
Ranier's Compounding Laboratory
Category
Drug — Injectable
Hazard
Affected units
2

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 (1)

  • All lots within expiry

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 15 recalled by Ranier's Compounding Laboratory 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 15 products in this recall →

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