D-390-2014 Class II Terminated
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;