Phenylephrine HCl recall: Sterility Concern
Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC…
Why was Phenylephrine HCl recalled?
Lack of Assurance of Sterility
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?
Lots: 01/18/19 3261 83067S Exp. 6/17/2019; 10/18/18 0212 83067S Exp. 3/17/2019; 10/23/18 7704 83067S Exp. 3/22/2019; 11/02/18 5909 83067S Exp. 4/1/2019; 10/31/18 8995 83067S Exp. 3/30/2019; 10/22/18 2570 83067S Exp. 3/21/2019; 10/18/18 6471 83067S Exp. 3/17/2019; 11/05/18 5527 83067S Exp. 4/4/2019; 11/05/18 0985 83067S Exp. 4/4/2019; 10/22/18 9234 83067S Exp. 3/21/2019; 10/30/18 6678 83067S Exp. 3/29/2019
- Product
- Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 500 mcg/5 mL (100 mcg per mL), 5mL Sterile single use syringe, NDC…
- Recalling firm
- Advanced Pharma Inc.
- Quantity
- 16075 syringes
- Distribution
- Nationwide
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)