The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1381-2015·Announced 2015-09-02

Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

Liberty Drug & Surgical is recalling Papaverine/Phentolamine/PGE-1 Injectable vials because process deficiencies may have compromised 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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which carries a risk of serious injury or hospitalization.

Plain-English summary

Liberty Drug & Surgical is recalling 2.5 mL vials of Papaverine/Phentolamine/PGE-1 Injectable (30 mg/1 mg/10 mcg/mL). The recall is limited to Lot # 05112015@19, which has an expiration date of 06/25/15.

The FDA identified process deficiencies in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. This lack of assurance of sterility poses a risk of infection or other adverse health consequences if the product is administered.

The affected product was distributed to physicians, medical facilities, and prescription-specific patients in New Jersey and New York. Patients 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
Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Manufacturer
Liberty Drug & Surgical
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 (2)

  • Lot #: 05112015@19
  • Exp 06/25/15

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 25 recalled by Liberty Drug & Surgical 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 25 products in this recall →

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