The Recall Desk
SevereFDA (Drugs)·D-1384-2015·Announced 2015-09-02

Liberty Drug Recalls Papaverine/Phentolamine/PGE-1 Injectable Due to Sterility Concerns

Liberty Drug & Surgical is recalling 2 vials of Papaverine/Phentolamine/PGE-1 Injectable because process deficiencies may have compromised 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 sterility compromise in an injectable product.

Plain-English summary

Liberty Drug & Surgical is recalling 2 vials of Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only. The product is identified by Lot # 05282015@7 and has an expiration date of 07/13/15.

The recall was initiated due to process deficiencies observed in sterile ophthalmic and injectable products that could have compromised the sterility of the product. This lack of assurance of sterility presents a potential risk to patients using the medication.

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/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
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 #: 05282015@7
  • Exp 07/13/15

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 →