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Recall Observatory FDA recall evidence

Drug product

Diabecline brand Topical Ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 04307-100-11

D-0949-2017

June 08, 2017

Class II

Product summary

Firm
Phillips Co.
Event
Event 77526
Status
Terminated
Classification
Class II
Quantity
100-200 bottles
Official record key
drug-enforcement:D-0949-2017

Official wording

Reason: GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.

Code information: All lots remaining within expiry.

Distribution pattern: Nationwide and United Kingdom

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP Deviations

Field note

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