phenylephrine 50 mg added to 0.9% sodium chloride recall: Sterility Concern
phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200…
Why was phenylephrine 50 mg added to 0.9% sodium chloride recalled?
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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: 36-251703, Exp. 8/28/2023; 36-251704, Exp. 8/29/2023
- Product
- phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200…
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 472 bags
- Distribution
- Nationwide in the USA
- Recall date
- August 9, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)