BuPROPion Hydrochloride Extended-Release Tablets recall: Failed Dissolution
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…
Why was BuPROPion Hydrochloride Extended-Release Tablets recalled?
Failed Dissolution Specifications; 9-monthstability timepoint
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) BR117002C, exp. date 11/2019; b) BR117003B and BR117004B, exp. date 11/2019
- Product
- 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…
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Quantity
- a) 3,072 bottles; b) 2,688 bottles
- Distribution
- Product was distributed to one customer who may have further distributed the product.
- Recall date
- March 13, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)