The Recall Desk
SevereFDA (Drugs)·D-390-2014·Announced 2014-01-01

Physicians Total Care Recalls Carisoprodol Tablets Due to Foreign Substance

Physicians Total Care is recalling Carisoprodol 350mg tablets because heavy metals and inactive components were found during routine stability testing.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the presence of heavy metals and foreign substances in a drug product meets the rubric criteria for a Severe rating.

Plain-English summary

Physicians Total Care, Inc. is recalling Carisoprodol 350mg tablets (NDC 54868-0816-8, 54868-0816-4, and 54686-0816-3) manufactured by Shasun Chemicals Drugs LTD. The recall involves 3,000 tablets distributed in California, Georgia, North Carolina, and Missouri.

The recall was initiated because heavy metals, including chromium and titanium, and inactive components of the product were visually observed during routine stability testing. The agency has classified this as a Class II recall.

Consumers who have these specific lot numbers (6REE, 6RED, 6REB) with an expiration date of 8/14 should stop using the product and contact their healthcare provider or the recalling firm for instructions.

The recalled product

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 bottl
Affected units
3,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • NDC 54868-0816-8
  • LOT: 6REE
  • EXP. 8/14
  • NDC 54868-0816-4
  • LOT: 6RED
  • NDC 54868-0816-3
  • LOT: 6REB

Distribution

Distributed in 4 states: