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.
Recall Summary Wecare Enema (4.5 Fl Oz), manufactured for Dynarex Corporation and distributed nationwide, is being recalled due to cGMP (current Good Manufacturing Practice) deviations. This is a Class I recall, the most serious classification, indicating the product may pose a health risk. The affected product has NDC number 67777-402-01 and was made in India.
- Recalling firm
- Blossom Pharmaceuticals
- Product
- 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.
- Reason
- cGMP deviations
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-10-31
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/f47a1eb5-9f3c-422e-9dff-4c874f9e77a7