Reported Mar 13, 2019 · Terminated
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC…
Jubilant Cadista Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Jubilant Cadista Pharmaceuticals, Inc. · 207 Kiley Dr · Salisbury, MD · 21801-2249
Is this the product you have?
- BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India
- Marketed byJubilant Cadista Pharmaceuticals Inc., Salisbury, MD
- Lot codes and dates
a) BR117002Cexp. date 11/2019b) BR117003B and BR117004Bexp. date 11/2019
- Amount recalled
- a) 3,072 bottles; b) 2,688 bottles
Why it was recalled
Failed Dissolution Specifications; 9-monthstability timepoint
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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