Teva Recalls Carbidopa and Levodopa Tablets Due to Potential Superpotency
Teva Pharmaceuticals USA is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg, due to the potential for superpotent tablets.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric for significant injury or property damage reports or high-risk scenarios.
Plain-English summary
Teva Pharmaceuticals USA is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottles. The recall is being conducted due to the potential for superpotent tablets, which means the medication may contain more active ingredients than specified.
The affected product is identified by Lot 29C220 with an expiration date of 11/15. The NDC number is 0093-0293-10. The product was manufactured in Israel by Teva Pharmaceutical IND, LTD. for Teva Pharmaceuticals USA. A total of 3,881 bottles were distributed nationwide.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or healthcare provider for replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options if they have been using this specific lot.
The recalled product
- Product
- Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,881
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 (2)
- lot 29C220
- Exp. 11/15
Distribution
Distributed nationwide across the United States.
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