Drug Enforcement D-66360-001

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

Status

Terminated

Classification

Class II

Report Date

October 16, 2013

Termination Date

July 25, 2014

Product Information

Product description
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.
Product quantity
1,002,394 tablets
Reason for recall
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US. No international. NATIONWIDE

Location & Firm

Recalling firm
Watson Laboratories Inc
Address
132 Business Center Dr, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-66360-001
Event ID
66360
Recall initiation date
September 23, 2013
Center classification date
October 9, 2013
Code info
Lot#: 580974AA and 580975AA. Exp: 09/14
More code info
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