Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Reported: October 31, 2018 Initiated: August 6, 2018 #D-0096-2019
Product Description
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Reason for Recall
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 27,816 bottles
- Distribution
- Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Recalled by Teva Pharmaceuticals USA. Units affected: 27,816 bottles.
Why was this product recalled? ▼
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2018. Severity: Moderate. Recall number: D-0096-2019.
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