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.
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 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.
- Manufacturer
- Liberty Drug & Surgical
- Category
- Drug — Injectable
- 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
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 →Related recalls
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