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Graviti Pharmaceuticals Private Limited: Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limit

DrugsSource: FDA (drug) · Date: 2025-10-29

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Graviti Pharmaceuticals Private Limited
Product
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03.
Reason / hazard
Failed Tablet/Capsule Specifications
Classification
Class II
Status
Ongoing
Distribution / sold at
Product was distributed to 1 distributor and 16 wholesalers/pharmacy retailers nationwide.
Recall initiated
2025-09-15
Code info
Batch # BPB124341A, Exp date: 10/2026
Product quantity
46,512/30 count bottles
Voluntary mandated
Voluntary: Firm initiated
City
Hyderabad
Country
India
Event id
97629
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