Drug recalls

ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios I…

PRITAM INTERNATIONAL PRIVATE LIMITED · CGMP Deviations.

Class IIOngoingD-0069-2027
Status
Ongoing
City
Haridwar
Country
India
Classification
Class II
Product type
Drugs
Event ID
99849
Recalling firm
PRITAM INTERNATIONAL PRIVATE LIMITED
Address 1
Khasra No. 138, Raipur Industrial Area
Address 2
Bhagwanpur
Postal code
N/A
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
US Nationwide.
Recall number
D-0069-2027
Product quantity
15,264 tubes
Reason for recall
CGMP Deviations.
Recall initiation date
20260910
Center classification date
20261019
Report date
20261028
Code info
Lot # LWP250047850611C, Exp Date: 12/22/2027; Lot # LWP260052612201C, Exp Date: 3/31/2028.
Product description

ARU, Toothpaste, Cavity Protection, 9 Ingredients, Cool Mint, (sodium fluoride 0.243%) Net Wt 3.5 oz (99g), Distributed by Ashtel Studios Inc., Ontario, California 91761, NDC 84140-785-35, Item # 88785, UPC 8 10147 88785

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.