Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
Reported: March 22, 2017 Initiated: February 7, 2017 #D-0517-2017
Product Description
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56
Reason for Recall
Failed Impurities/Degradation Specifications
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 7,628 HDPE bottles (228,840 tablets)
- Distribution
- Nationwide
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56. Recalled by Teva Pharmaceuticals USA. Units affected: 7,628 HDPE bottles (228,840 tablets).
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 22, 2017. Severity: Moderate. Recall number: D-0517-2017.
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