D-390-2014 Class II Terminated

Recalled by Physicians Total Care, Inc. — Tulsa, OK

Recall Details

Product Type
Drugs
Report Date
January 1, 2014
Initiation Date
November 22, 2013
Termination Date
March 2, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,000 tablets

Product Description

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 Pattern

CA, GA, NC, and MO

Code Information

NDC 54868-0816-8, LOT: 6REE, EXP. 8/14; NDC 54868-0816-4, LOT: 6RED, EXP. 8/14; NDC 54868-0816-3, LOT: 6REB, EXP. 8/14;