The Recall Desk
SevereFDA (Drugs)·D-1399-2015·Announced 2015-09-02

Methadone Injection Recalled Due to Sterility Assurance Concerns

Liberty Drug & Surgical is recalling Methadone 10 mg/mL Injection vials because process deficiencies could 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 and involves a sterile injectable product where sterility assurance was compromised, posing a significant risk of serious injury or infection.

Plain-English summary

Liberty Drug & Surgical is recalling 5 vials of Methadone 10 mg/mL Injection, 10 mL vial, Rx only. The recall involves specific lots: 05012015@5 (Exp 06/16/15) and 05152015@10 (Exp 06/30/15).

The recall was initiated due to a lack of assurance of sterility. Process deficiencies were observed in the sterile ophthalmic and injectable products, which could have compromised the sterility of the product.

The affected products were distributed to physicians, medical facilities, and prescription-specific patients in New Jersey and New York. 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
Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
Affected units
5

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 #: 05012015@5
  • Exp 06/16/15
  • 05152015@10
  • Exp 06/30/15

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 →