The Recall Desk
SevereFDA (Drugs)·D-1427-2019·Announced 2019-07-03

Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns

Premier Pharmacy Labs is recalling 6,423 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.

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 failure in a sterile injectable medication.

Plain-English summary

Premier Pharmacy Labs Inc is recalling 6,423 syringes of Succinylcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe. The product is identified by NDC 69623-239-15 and barcode 0 69623 23915 0. The recall covers all lots remaining within their expiry dates.

The recall was initiated following an FDA inspection that identified insufficient environmental controls, potential cross-contamination, and a lack of product-specific process validations. These deficiencies can result in a lack of sterility assurance for the medication.

The affected product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for this specific NDC and barcode and discontinue use if found.

The recalled product

Product
SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-15, barcode 0 69623 23915 0.
Affected units
6,423

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 (1)

  • All lots remaining within expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 18 recalled by Premier Pharmacy Labs Inc 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 18 products in this recall →