The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0788-2016·Announced 2016-04-06

Walter's Pharmacy Recalls Lidocaine Nebulizer Solution Due to Sterility Concerns

Walter's Pharmacy is recalling Lidocaine Nebulizer 2% Solution because the product lacks assurance of sterility. The recall affects 5 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 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 with potential for adverse health consequences are rated as Severe (4), particularly when the hazard involves sterility assurance for a medical product.

Plain-English summary

Walter's Pharmacy is recalling Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles. The recall is due to a lack of assurance of sterility. The product is prescription-only and carries NDC 99999-9000-99.

The recall involves 5 bottles with lot numbers 010516 and 012016. These products were distributed in Pennsylvania. Walter's Pharmacy is located at 401 N 17th St, Allentown, PA.

Consumers who have this product should contact their healthcare provider or Walter's Pharmacy for instructions on how to proceed. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99
Manufacturer
Walter's Pharmacy
Category
Drug — Nebulizer Solution
Hazard
Affected units
5

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 #: 010516
  • 012016

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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