Dabur India Limited — Class II: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield L
Dabur India Limited has initiated a Class II recall of Med Pride Hydrocortisone Cream 1% (1 oz tubes) due to CGMP deviations and deficiencies observed during an FDA inspection. The recall is currently classified as ongoing and involves product manufactured for Shield Line LLC.
This recall affects Dabur India Limited, Shield Line LLC, and distributors or retailers handling the specific UPC 3 52410 30503 0. It also impacts quality and compliance departments responsible for monitoring contract manufacturing and CGMP adherence.
A Class II recall for CGMP deviations suggests that while the health hazard may be temporary or reversible, the underlying manufacturing processes failed to meet regulatory standards. This indicates potential systemic issues within the facility's quality management system or production controls that were identified during a physical FDA inspection. For companies utilizing international contract manufacturers, this highlights the regulatory risks associated with facility-level deficiencies.
Quality units should review contract manufacturing agreements to ensure robust oversight of overseas facilities. Compliance teams may want to audit current CGMP documentation for topical drug products to ensure alignment with inspectional expectations. Monitoring of the 'Ongoing' status of this recall is advised to determine if the scope expands.
Class II. Reason: CGMP Deviations; deficiencies observed during FDA inspection. Product: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.. Firm: Dabur India Limited (Dadra And Nagar Haveli India). Status: Ongoing.
Open in openFDA / FDA.gov