FDA-Drug2025-12-10Class IIPROCESSING DEFECT

Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.

OTHERNationwide distributionDrugs
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Hazard

cGMP deviations

Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
18912 containers
Manufactured in
Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim, Bardej, Goa, India
Products
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0203-2026

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