Oxytocin 30 units in 0.9% Sodium Chloride recall: Sterility Concern
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only…
Why was Oxytocin 30 units in 0.9% Sodium Chloride recalled?
Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot, exp: 170619-011, 9/17/2017; 170707-007, 10/5/2017; 170713-009, 10/11/2017
- Product
- Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only…
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Quantity
- N/A
- Distribution
- SSM Health entities in the state of MO only
- Recall date
- January 3, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)