November 2013 FDA Recall Drug by Physicians Total Care, Inc. (D-390-2014 - Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.)

This Class II drug recall was voluntarily initiated by Physicians Total Care, Inc. on November 22, 2013 for the product Drug. The FDA reported the reason for recall as presence of foreign substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.. The product was distributed in CA, GA, NC, and MO and the recall is currently terminated.

Recall Number: D-390-2014

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.
Initiated
11-22-2013
Reported
01-01-2014
Quantity
3,000 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67118
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Physicians Total Care, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
CA, GA, NC, and MO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-02-2016
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 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