FDA recall D-390-2014

Product

Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only. Mfd by: Shasun Chemicals Drugs LTD, Pondicherry, INDIA. Repacked and Distributed by: Physicians Total Care, Inc., Tulsa, OK 74146. 90 count bottle: NDC: 54868-0816-8, 60 count bottle: NDC: 54868-0816-4, 30 count bottle: NDC: 54686-0816-3.

Reason for recall

Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.

Distribution

CA, GA, NC, and MO

Key facts

Status

Terminated

Initiation date

2013-11-22

Report date

2014-01-01

Termination date

2016-03-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-390-2014