The Recall Desk
SevereFDA (Drugs)·D-0960-2017·Announced 2017-07-19

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.

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 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.

Related recalls

Same hazard · dissolution failure

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