The Recall Desk
SevereFDA (Drugs)·D-1400-2015·Announced 2015-09-02

Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

Liberty Drug & Surgical is recalling specific lots of Papaverine/Phentolamine/Atropine/PGE-1 Injectable due to process deficiencies that could compromise 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. According to the rubric, FDA Class II recalls with potential for significant injury (such as sterility compromise in injectables) are categorized as Severe (Score 4).

Plain-English summary

Liberty Drug & Surgical is recalling 6 vials of Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial. The affected lots are 04202015@18 (Exp 06/04/15) and 05192015@16 (Exp 07/03/15). The product is prescription-only and was distributed to physicians, medical facilities, and specific patients in New Jersey and New York.

The recall was initiated because process deficiencies were observed in the sterile ophthalmic and injectable products. These deficiencies could have compromised the sterility of the product, posing a risk of infection or other adverse health consequences.

Patients and healthcare providers who have received this product should contact their healthcare provider for guidance on alternative treatments or further evaluation. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Affected units
6

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 #: 04202015@18
  • Exp 06/04/15
  • 05192015@16
  • Exp 07/03/15

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 →