Teva Recalls Risedronate Sodium Tablets for Failed Dissolution Specifications
Teva Pharmaceuticals is recalling 6,800 cartons of Risedronate Sodium Delayed-release Tablets, 35 mg, because they failed dissolution specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Teva Pharmaceuticals USA is recalling 6,800 cartons of Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week. The affected product is identified by Lot # 34027040A and an expiration date of 10/17. The recall is being conducted because the tablets failed to meet dissolution specifications.
The affected product was distributed nationwide in the USA and Puerto Rico. The product is a prescription-only medication (Rx only) packaged in 4 blisters per carton.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,800
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 # 34027040A
- Exp 10/17
Distribution
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