Recalls / Class II
Class IID-0612-2022
Product
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC., ELK GROVE VILLAGE, IL 60007. NDC 36800-907-10
- Brand name
- Topcare Nasal
- Generic name
- Oxymetazoline Hydrochloride
- Active ingredient
- Oxymetazoline Hydrochloride
- Route
- Nasal
- NDC
- 36800-907
- FDA application
- M012
- Affected lot / code info
- Batch: 1BK0716, Exp 12/31/2022
Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Recalling firm
- Firm
- Perrigo Company PLC
- Manufacturer
- Topco Associates LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Quantity
- 19,584 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-10-26
- FDA classified
- 2022-02-23
- Posted by FDA
- 2022-03-02
- Terminated
- 2023-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0612-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.