Atropine Sulfate 0.01% in 0.9% Sodium Chloride recall: Sterility Concern
Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding…
Why was Atropine Sulfate 0.01% in 0.9% Sodium Chloride recalled?
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
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?
All unexpired lots; Expirations dates of 11/13/2016 to 01/02/2017
- Product
- Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding…
- Recalling firm
- Leiter's Compounding
- Quantity
- 76,315 total units, all products
- Distribution
- Nationwide
- Recall date
- October 19, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)