InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC
Failed Dissolution Specifications; during stability testing
Recall notice
Failed Dissolution Specifications; during stability testing
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Source Page by GovInfoNow · govinfonow.com/recall/40778-invagen-pharmaceuticals-inc-recalls-bupropion-hcl-extended-release-tablets-usp · Recall date March 15, 2018 · FDA enforcement record: FDA #D-0619-2018
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“InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC.” GovInfoNow, recall dated March 15, 2018. https://govinfonow.com/recall/40778-invagen-pharmaceuticals-inc-recalls-bupropion-hcl-extended-release-tablets-usp. Based on FDA recall #D-0619-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0619-2018%22&limit=1).
How to tell if you have this one
- Brand
InvaGen Pharmaceuticals, Inc.- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide- NDC
69097-877-02, 69097-877-03, 69097-877-07, 69097-877-12, 69097-878-02, 69097-878-03, 69097-878-07, 69097-878-12, 69097-879-02, 69097-879-03, 69097-879-07, 69097-879-12
| Recall number | Product, codes & lots |
|---|---|
| D-0618-2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03; Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018 |
| D-0619-2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788; a) Lot I1606609 and Lot I1606610 Exp. Date 05/2018; Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05/2018; Lot I1607847 and Lot I1607845 Exp Date 06/2018; Lot I1610639 Exp Date 09/2018 |
Contact InvaGen Pharmaceuticals, Inc.
We’ve drafted a message you can send InvaGen Pharmaceuticals, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0619-2018 — InvaGen Pharmaceuticals, Inc. InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Hello, I own a InvaGen Pharmaceuticals, Inc. recalls buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC that is covered by recall D-0619-2018 from InvaGen Pharmaceuticals, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0619-2018 (March 15, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0619-2018 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.