Status
Terminated
Drug Enforcement 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.
Classification
Class II
Report Date
January 1, 2014
Termination Date
March 2, 2016
Product Information
- 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.
- Product quantity
- 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.
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- CA, GA, NC, and MO
Location & Firm
- Recalling firm
- Physicians Total Care, Inc.
- Address
-
12515 E 55th St Ste 100, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-390-2014
- Event ID
- 67118
- Recall initiation date
- November 22, 2013
- Center classification date
- December 26, 2013
- 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;
- More code info
- —