Class III
Terminated
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 100 mg, packaged in a) 60-count bottles (NDC 59746-315-60) and b) 100-count bottles (NDC 59746-315-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.
This recall has been terminated (originally issued April 19, 2017).
- Recall Initiated
- April 8, 2016
- Posted
- April 19, 2017
- Recall Number
- D-0669-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20,882 bottles
- Firm Location
- Salisbury, MD, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #s: a) BU15001B, BU15003D, Exp 12/16; b) BU15002A, Exp 12/16
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