SSM St. Clare Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded Neostigmine Methylsulfate syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk injectable drug with a sterility hazard (microbial growth detected in simulation). Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringes (NDC: 88890-0329-01). The affected product is a compounded injectable drug intended for hospital or office use only. The specific lot number is 170705-002, with a date of 10/03/2017.
The recall was initiated due to a lack of sterility assurance. Microbial growth was detected during a routine simulation of the manufacturing process. The source text explicitly states that no batches of distributed product have been identified as actually containing microorganisms.
The product was distributed only to SSM Health entities in the state of Missouri. Because this is a prescription-only injectable drug used in clinical settings, there are no specific instructions for general consumers. Healthcare facilities should discontinue use of the affected lot and contact the recalling firm for further instructions.
The recalled product
- Product
- Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01
- Category
- Drug — Injectable
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 (2)
- Lot: 170705-002
- 10/03/2017
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 10 recalled by SSM Health Care St. Louis DBA SSM St. Clare Health Center 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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