Recalls / Class II
Class IID-0517-2017
Product
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
- Affected lot / code info
- Lot 30227056A; Exp. 03/17
Why it was recalled
Failed Impurities/Degradation Specifications
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, N/A, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 7,628 HDPE bottles (228,840 tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-07
- FDA classified
- 2017-03-10
- Posted by FDA
- 2017-03-22
- Terminated
- 2018-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0517-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.