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.
Reported: April 19, 2017 Initiated: April 8, 2016 #D-0669-2017
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Details
- Recalling Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Units Affected
- 20,882 bottles
- Distribution
- Nationwide in the USA
- Location
- Salisbury, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Jubilant Cadista Pharmaceuticals, Inc.. Units affected: 20,882 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 19, 2017. Severity: Low. Recall number: D-0669-2017.
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