Drug Enforcement D-0457-2023

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

March 15, 2023

Termination Date

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Product Information

Product description
Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
Product quantity
995 bottles
Reason for recall
CGMP Deviations
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide in the USA and Worldwide through e-commerce and trade shows

Location & Firm

Recalling firm
Pharmedica USA, LLC
Address
2836 W Deer Valley Rd Bldg E2

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0457-2023
Event ID
91707
Recall initiation date
February 14, 2023
Center classification date
March 10, 2023
Code info
Lot #: 1808051, Exp.: 01/01/2027
More code info
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