drugs Class II Updated 2014-01-01

Physicians Total Care, Inc. recalls Carisoprodol IV ( Carisoprodol Tablets USP) 350mg, RX only.

Recalled 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.

Hazard / Issue

Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing.

Issued by

FDA

Affected States: CA, GA, NC, MO
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;
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