FDA Drug Class II — Moderate

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

Hazard

Failed Impurities/Degradation Specifications

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Products

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
Brand
Teva Pharmaceuticals USA
UPC
Lot 30227056A; Exp. 03/17

Units Affected

7,628 HDPE bottles (228,840 tablets)

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