The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0010-2017·Announced 2016-10-19

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard
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.

See all 9 products in this recall →

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