Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution recall: Sterility Concern
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Why was Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution 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?
Lot #: BPPTC08717, Exp. 11/7/17
- Product
- Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
- Recalling firm
- Bella Pharmaceuticals, Inc.
- Quantity
- 6 bottles
- Distribution
- Nationwide within USA
- Recall date
- September 20, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)