Drug 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.
D-390-2014
Product summary
- Event
- Event 67118
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,000 tablets
- Official record key
drug-enforcement:D-390-2014
Official wording
Reason: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.
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;
Distribution pattern: CA, GA, NC, and MO
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance