The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0798-2016·Announced 2016-04-06

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

Walter's Pharmacy is recalling Tobramycin 14 mg/mL Ophthalmic Solution because the product lacks assurance of sterility. The recall affects 10 mL bottles 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure in an ophthalmic solution) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Walter's Pharmacy is recalling specific bottles of Tobramycin 14 mg/mL Ophthalmic Solution. The recall was initiated because the product lacks assurance of sterility. The affected product is a 10 mL bottle, prescription only, with NDC 99999-9996-60 and Lot # 020216.

The recall is limited to the state of Pennsylvania. Walter's Pharmacy is the recalling firm. The source text does not specify the number of units recalled or report any illnesses or injuries associated with 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
Tobramycin 14 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9996-60
Manufacturer
Walter's Pharmacy
Category
Drug — Ophthalmic Solution
Hazard
Affected units
1

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 #: 020216

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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