The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-161-2013·Announced 2013-02-20

Lee Pharmaceuticals Recalls 12-Hour Sinus Nasal Spray Due to Microbial Contamination

Lee Pharmaceuticals is recalling 12-Hour Sinus Nasal Spray products due to microbial contamination identified during testing.

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 and involves microbial contamination, which fits the rubric criteria for Severe severity (FDA Class II with potential for hospitalization or significant injury).

Plain-English summary

Lee Pharmaceuticals, Inc. is recalling 32,460 bottles of 12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL). The recall is due to microbial contamination identified during testing. The affected products are distributed nationwide under various labels, including Best Choice, Discount Drug Mart, Duane Reade, Lee Pharmaceuticals, Premier Value, Quality Choice, Rite Aid, and Select Brand Distributors.

The specific lots involved are 2111 and 2114, with an expiration date of 04/14. The products are identified by specific UPC codes and NDC numbers listed in the recall notice. This recall is classified as FDA Class II.

Consumers should stop using the affected products and return them to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
12-Hour Sinus (oxymetazoline hydrochloride) Nasal Spray, 0.05%, 1 FL OZ (30 mL), labeled as a) 12 HOUR SINUS Nasal Spray, Best Choice, Proudly Distributed By: Valu Merchandisers, Co., Kansas City, MO 64111, UPC 0 70038 61226 1; b) Nasal Spray Sinus, Distributed by Discount Drug…
Manufacturer
Lee Pharmaceuticals, Inc
Category
Drug — Nasal Spray
Hazard
Affected units
32,460

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 #: 2111 and 2114
  • Exp 04/14

Distribution

Distributed nationwide across the United States.

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