Class III ยท Low risk
Quetiapine Fumarate Extended-Release Tablets
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
National Drug Code
Is NDC 0904-6802-61 recalled?
Quetiapine · 100 BLISTER PACK in 1 CARTON (0904-6802-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Yes — this exact package was recalled
1 FDA recall names the code 0904-6802-61 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
- Active ingredient
- Quetiapine
- Strength
- QUETIAPINE FUMARATE 150 mg/1
- Form
- Tablet, Film Coated, Extended Release · Oral
- Labeler
- Major Pharmaceuticals
- Type
- Human Prescription Drug
- Product code
- 0904-6802
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.