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Recall Observatory FDA recall evidence

Drug product

Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880.

D-66360-001

September 23, 2013

Class II

Product summary

Firm
Watson Laboratories Inc
Event
Event 66360
Status
Terminated
Classification
Class II
Quantity
1,002,394 tablets
Official record key
drug-enforcement:D-66360-001

Official wording

Reason: Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.

Code information: Lot#: 580974AA and 580975AA. Exp: 09/14

Distribution pattern: US. No international. NATIONWIDE

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.