PHENYLephrine added to 0.9% sodium chloride recall: Sterility Concern
PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580…
Why was PHENYLephrine added to 0.9% sodium chloride recalled?
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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 # 37-884272, Exp 05/03/2023; 37-887513, Exp 05/16/2023; 37-888083, Exp 05/18/2023; 37-889123, 37-889423, Exp 05/23/2023; 37-891563, Exp 06/01/2023; 37-892577, 37-892582, Exp 06/06/2023; 37-893248, 37-893257, Exp 06/08/2023; 37-894436, Exp 06/13/2023; 37-895805, Exp 06/19/2023; 37-898324, Exp 06/28/2023
- Product
- PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580…
- Recalling firm
- Central Admixture Pharmacy Services, Inc.
- Quantity
- 6407 bags
- Distribution
- Nationwide in the USA.
- Recall date
- May 31, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)