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U.S. Department of Health and Human Services

Enforcement Report - Week of January 1, 2014

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Product Detail

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.
Recall Number D-390-2014
Classification Class II
Code Info 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;
Product Distributed Qty 3,000 tablets
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.

Event Detail

Event Id 67118
Product Type Drugs
Status Ongoing
Recalling Firm Physicians Total Care, Inc.
City Tulsa
State OK
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-22
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern CA, GA, NC, and MO