FDA recall D-66360-001

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.

Reason for recall

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

Distribution

US. No international. NATIONWIDE

Key facts

Status

Terminated

Initiation date

2013-09-23

Report date

2013-10-16

Termination date

2014-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-66360-001