Teva Recalls Paliperidone Extended-Release Tablets Due to Dissolution Failure
Teva Pharmaceuticals is recalling 360 bottles of Paliperidone Extended-Release Tablets because one tablet failed a routine stability test for drug release.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Teva Pharmaceuticals is recalling 360 bottles of Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles. The product is distributed nationwide in the US. The specific lot number is 1160682A, with an expiration date of 06/18.
The recall was initiated because a drug release test result obtained during routine 9-month stability testing was below specification for one tablet. Teva cannot currently exclude the potential for additional tablets in the lot to be below specification.
Consumers who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on how to proceed. The product is prescription-only.
The recalled product
- Product
- Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
- Manufacturer
- Teva Pharmaceuticals
- Category
- Drug — Antipsychotic
- Hazard
- Affected units
- 360
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: 1160682A
- EXP. 06/18
Distribution
Distributed nationwide across the United States.
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