FDA recall D-1409-2012

Product

Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10

Reason for recall

Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)

Distribution

Ohio

Key facts

Status

Terminated

Initiation date

2012-05-16

Report date

2012-07-11

Termination date

2013-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1409-2012