The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0791-2016·Announced 2016-04-06

Walter's Pharmacy Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns

Walter's Pharmacy is recalling Tobramycin 15mg/mL Ophthalmic Solution because the product lacks assurance of sterility. The recall affects specific lots 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 in this case a critical sterility failure for an ophthalmic product, align with the 'Severe' criteria (Score 4), as it is not a Class I recall but involves a significant health risk.

Plain-English summary

Walter's Pharmacy is recalling Tobramycin 15mg/mL Ophthalmic Solution, packaged in 5mL and 10mL bottles. The recall is being conducted because the product lacks assurance of sterility. The affected product is prescription-only and is identified by NDC 99999-9996-35.

The recall covers two specific lots: 020316 and 011216. The product was distributed in Pennsylvania. Walter's Pharmacy is located at 401 N 17th St., Allentown, PA.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35
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 (1)

  • Lot #: 020316 and 011216

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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