FDA recall D-0330-2015

Product

Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141; Manufactured by: Aurobindo Pharma Limited, Unit-VII (SEZ), Mahaboob Nagar (Dt), AP-509302, INDIA, NDC 16714-662-01, UPC 3 16714-662-01 5.

Reason for recall

Failed Tablet/Capsule Specifications: Complaints of empty capsules received.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-10-17

Report date

2015-01-14

Termination date

2016-05-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dayton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0330-2015