SSM St. Clare Recalls Phenylephrine Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded phenylephrine 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
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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving injectable drugs where sterility assurance is critical, even if no actual contamination in distributed product has been confirmed.
Plain-English summary
SSM Health Care St. Louis DBA SSM St. Clare Health Center is recalling specific lots of Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL syringes. The recall is due to a lack of sterility assurance, as microbial growth was detected during a routine simulation of the manufacturing process.
The affected product is a compounded injectable drug intended for hospital or office use only. The specific lots involved are 170622-007 (expiration date 9/20/2017) and 170710-007 (expiration date 10/8/2017). The product was distributed only to SSM Health entities within the state of Missouri.
The FDA has not identified any batches of distributed product that actually contain microorganisms. This recall is classified as Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences. Healthcare facilities should discontinue use of the affected lots and follow standard procedures for returning or destroying recalled pharmaceuticals.
The recalled product
- Product
- Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01
- 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 (5)
- Lot
- exp: 170622-007
- 9/20/2017
- 170710-007
- 10/8/2017
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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