The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0786-2016·Announced 2016-04-06

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

Walter's Pharmacy is recalling specific lots of Cefazolin 50 mg/mL Ophthalmic Solution because the sterility of the product cannot be assured.

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, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with non-sterile ophthalmic products.

Plain-English summary

Walter's Pharmacy is recalling four bottles of Cefazolin 50 mg/mL Ophthalmic Solution, 10mL bottles, prescription only. The recall is due to a lack of assurance of sterility. The affected products are identified by lot numbers 012216, 012816, 012616, and 020616.

The recalled products were distributed in Pennsylvania. The National Drug Codes (NDC) for the affected items are 99999-9999-69 and 89999-9001-04.

Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04
Manufacturer
Walter's Pharmacy
Category
Drug — Ophthalmic Solution
Hazard
Affected units
4

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 (4)

  • Lot #: 012216
  • 012816
  • 012616
  • 020616

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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