Recalls / Class II
Class IID-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.
- Affected lot / 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;
Why it was recalled
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
Recalling firm
- Firm
- Physicians Total Care, Inc.
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 12515 E 55th St Ste 100, N/A, Tulsa, Oklahoma 74146-6234
Distribution
- Quantity
- 3,000 tablets
- Distribution pattern
- CA, GA, NC, and MO
Timeline
- Recall initiated
- 2013-11-22
- FDA classified
- 2013-12-26
- Posted by FDA
- 2014-01-01
- Terminated
- 2016-03-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-390-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.