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Recall Observatory FDA recall evidence

Drug product

Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.

D-0636-2026

June 02, 2026

Class II

Product summary

Firm
Dabur India Limited
Event
Event 99137
Status
Ongoing
Classification
Class II
Quantity
4374 tubes
Official record key
drug-enforcement:D-0636-2026

Official wording

Reason: CGMP Deviations; deficiencies observed during FDA inspection

Code information: Lot# 001, 002, 003, 004, 005, 006, 010, 011, 012, 013, 014, 016, 017, 018, 019, 020, Within Expiry.

Distribution pattern: US Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations; deficiencies