FDA-Drug2025-12-10Class IIPROCESSING DEFECT
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
Hazard
cGMP deviations
Intended for
All ages
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
2400 containers
Manufactured in
Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim, Bardej, Goa, India
Products
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0213-2026Want us to check the next one for you?
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