Leiter's Compounding Recalls Atropine Sulfate Ophthalmic Solution Due to Sterility Concerns
Leiter's Compounding is recalling Atropine Sulfate 0.01% ophthalmic solution because the filters used to produce the products were recalled, raising concerns about sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of assurance of sterility in an ophthalmic solution, which poses a risk of serious injury or death if contaminated.
Plain-English summary
Leiter's Compounding is voluntarily recalling Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle. The recall is being conducted because the products were produced using filters that were themselves recalled, resulting in a lack of assurance of sterility.
The recall affects 76,315 total units distributed nationwide. The affected products have expiration dates ranging from 11/13/2016 to 01/02/2017. The recall includes all unexpired lots of the product.
Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- 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, San Jose, CA --- NDC 70360-011-39
- Manufacturer
- Leiter's Compounding
- Category
- Drug — Ophthalmic Solution
- Affected units
- 76,315
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All unexpired lots
- Expirations dates of 11/13/2016 to 01/02/2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Leiter's Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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