Premier Pharmacy Labs Recalls NeoStigmine Syringes Due to Sterility Concerns
Premier Pharmacy Labs is recalling NeoStigmine Methylsulfate syringes because routine testing of other lots detected microbial contamination risks.
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 risk of microbial contamination in a sterile injectable drug, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 600 single-dose syringes of NeoStigmine Methylsulfate (1 mg/mL), 3mg per 3mL. The affected product is identified by Lot NEO022218SVDS and has a beyond-use date of 8/21/2018. The product was distributed nationwide in the USA.
The recall was initiated due to a lack of assurance of sterility. Microbial contamination was detected during routine testing of subsequent, unreleased product lots. This issue was caused by an interaction between the product syringe and the tamper-evident container closure, which may result in the potential introduction of microorganisms into the products.
Healthcare providers and patients should stop using the recalled syringes and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable
- Affected units
- 600
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)
- Lot: NEO022218SVDS BUD: 8/21/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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.
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