The Recall Desk
SevereFDA (Drugs)·D-1386-2015·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 could have compromised the product's 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 and involves a lack of assurance of sterility in an injectable product, which poses a risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

Liberty Drug & Surgical is recalling 2.5 mL vials of Papaverine/Phentolamine/PGE-1 Injectable (Lot # 06042015@9, Exp 07/19/15). The recall is being conducted due to process deficiencies observed in the sterile ophthalmic and injectable products, which could have compromised the sterility of the product.

The affected product was distributed to physicians, medical facilities, and prescription-specific patients in New Jersey and New York. The source text does not report any specific illnesses or injuries associated with this recall.

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
Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 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 #: 06042015@9
  • Exp 07/19/15

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 →