West-Ward Recalls Carisoprodol Tablets Due to Foreign Substance Presence
West-Ward Pharmaceutical Corp. is recalling 20,534 bottles of Carisoprodol Tablets, USP 350 mg, because heavy metals and inactive components were visually observed 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. Per the rubric, FDA Class II recalls are mapped to a score of 4 (Severe), particularly given the presence of heavy metals which can cause significant health issues.
Plain-English summary
West-Ward Pharmaceutical Corp. is recalling 20,534 bottles of Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. The product is distributed by West-Ward Pharmaceutical Corp. in Eatontown, NJ, and manufactured by Shasun Chemicals and Drugs Limited in India. The recall covers specific lots with expiration dates in August 2014 and July 2015, identified by NDC 0143-9749-10.
The recall was initiated because heavy metals (including chromium and titanium) and inactive components of the product were visually observed during routine stability testing. This indicates the presence of a foreign substance in the medication.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase for a refund or replacement. The FDA classifies this recall as Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
- Manufacturer
- West-Ward Pharmaceutical Corp.
- Category
- Drug — Prescription Medication
- Affected units
- 20,534
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 (13)
- NDC 0143-9749-10 Lot: 1) 10BR001B
- Exp Aug-2014 2) 10BR002B
- Exp Aug-2014 3) 10BR003B Exp
- Aug-2014 4) 10BR004B Exp
- Aug-2014 5) 10BR005B Exp
- Aug-2014 6) 10BR006B Exp
- Aug-2014 7) 11BR001B Exp
- Aug-2014 8) 11BR002B Exp
- Jul-2015 9) 11BR003B Exp
- Jul-2015 10) 11BR004B Exp
- Jul-2015 11) 11BR005B Exp
- Jul-2015 12) 11BR006B Exp
- Jul-2015
Distribution
Distributed nationwide across the United States.
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