The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0794-2016·Announced 2016-04-06

Walter's Pharmacy Recalls Acetylcysteine Eye Drops Due to Sterility Concerns

Walter's Pharmacy is recalling two bottles of Acetylcysteine 10% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in an ophthalmic product presents a significant risk of infection, aligning with the Severe classification for Class II recalls with potential for serious harm.

Plain-English summary

Walter's Pharmacy is recalling two bottles of Acetylcysteine 10% Ophthalmic Solution, 10mL, prescription only. The recall is being conducted because of a lack of assurance of sterility. The affected product is identified by NDC 99999-9018-33 and includes lot numbers 012116 and 012516.

The recalled product was distributed in Pennsylvania. Walter's Pharmacy is the recalling firm and the manufacturer of the product.

Consumers who have this product should stop using it and contact their healthcare provider or Walter's Pharmacy for further instructions.

The recalled product

Product
Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33
Manufacturer
Walter's Pharmacy
Category
Drug — Ophthalmic Solution
Hazard
Affected units
2

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)

  • Lot #: 012116
  • 012516

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 13 recalled by Walter's Pharmacy 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 13 products in this recall →

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