FDA recall D-1422-2012

Product

Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.

Reason for recall

Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-03-09

Report date

2012-07-25

Termination date

2012-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buffalo Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1422-2012