Phenylephrine Hydrochloride Ophthalmic Solution recall: Sterility Concern
Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
Why was Phenylephrine Hydrochloride Ophthalmic Solution recalled?
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
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 #: 031908A, Exp 03/20
- Product
- Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.
- Recalling firm
- Akorn, Inc.
- Quantity
- 60,176 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- October 9, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)