Cyclosporin 0.1% Opth Solution recall: Sterility Concern
Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Why was Cyclosporin 0.1% Opth Solution recalled?
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
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 #: 062915, Exp 09/29/2015; 070915, Exp 10/09/2015; 073015, Exp 10/30/2015; 080315, Exp 11/03/2015; and 080615, Exp 11/06/2015
- Product
- Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
- Recalling firm
- Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Quantity
- 7 dropper bottles
- Distribution
- Nationwide
- Recall date
- November 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)