The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0609-2022·Announced 2022-03-02

Signature Care Nasal Decongestant Recalled for Contaminated Excipient

Perrigo Company PLC is recalling Signature Care Nasal Decongestant because the product was manufactured with a contaminated excipient that was itself recalled by its supplier. The recall affects approximately 14,784 bottles distributed nationwide.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving a CGMP deviation related to a contaminated excipient. The source text does not report any illnesses, injuries, or adverse events associated with the product. In the absence of reported harm and without evidence of high-risk pathogens or direct safety hazard, this qualifies as a moderate-severity precautionary recall.

Plain-English summary

Perrigo Company PLC is recalling Signature Care Nasal Decongestant (Oxymetazoline Hydrochloride 0.05%), 1 FL Oz (30 mL) bottles, due to Current Good Manufacturing Practice (CGMP) deviations. The products were manufactured using a contaminated excipient that had been recalled by the excipient supplier.

The affected product includes NDC 21130-813-10 with the following batch codes and expiration dates: Batch 1BK0716 (Exp 12/31/2022); Batch 1FK1251 (Exp 02/28/2023); and Batch 1HK1196 (Exp 02/28/2023). Approximately 14,784 bottles were distributed nationwide in the USA through Better Living Brands LLC.

Consumers who have purchased this product should stop using it and contact their pharmacist or healthcare provider if they have questions or concerns. The product should be returned to the place of purchase.

The recalled product

Product
SIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HYDROCHLORIDE)
Brand
SIGNATURE CARE NASAL DECONGESTANT
Manufacturer
Perrigo Company PLC
Category
Drug — Nasal Decongestant / OTC
Hazard
Affected units
14,784

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 (5)

  • Batch: 1BK0716
  • Exp 12/31/2022
  • 1FK1251
  • 1HK1196
  • Exp 02/28/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 51 recalled by Perrigo Company PLC 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 51 products in this recall →

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