Phenylephrine HCL 80mg in 0.9% Sodium Chloride recall: Sterility Concern
Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Why was Phenylephrine HCL 80mg in 0.9% Sodium Chloride recalled?
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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 # 20180328@25, Exp 06/26/2018
- Product
- Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
- Recalling firm
- SCA Pharmaceuticals, LLC
- Quantity
- 196 bags
- Distribution
- Product was distributed throughout the United States.
- Recall date
- July 11, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)