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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Physicians Total Care, Inc.
- Category
- Drug — Prescription Medication
- 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
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