Phenylephrine 2.5% recall: Sterility Concern
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401…
Why was Phenylephrine 2.5% recalled?
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of 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 Numbers: 10003, Exp 04/05/17; 10018, Exp 04/17/17; 10023, Exp 04/23/17; 10025, Exp 04/24/17; 10027, Exp 04/29/17; 11011, 11012, Exp 05/07/17; 11024, 11026, Exp 05/14/17; 11029, Exp 05/16/17; 11030, Exp 05/17/17; 11032, Exp 05/21/17; 11045, Exp 06/04/17; 12008, Exp 06/13/17; 12014, 12015, Exp 06/20/17; 12022, 12024, Exp 06/28/17; 13001, 13002, Exp 07/03/17; 13011, 13012, Exp 07/09/17.
- Product
- Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401…
- Recalling firm
- Isomeric Pharmacy Solution, LLC
- Quantity
- 5,165 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- May 3, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)