Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; 6 month time point
National Drug Code
Is NDC 68382-0354-05 recalled?
bupropion · 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-354-05)
Yes — this exact package was recalled
2 FDA recalls name the code 68382-0354-05 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
- bupropion
- Strength
- BUPROPION HYDROCHLORIDE 300 mg/1
- Form
- Tablet, Extended Release · Oral
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Type
- Human Prescription Drug
- Product code
- 68382-0354
Recalls naming this package
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
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
- 68382-0021 Venlafaxine 2
- 68382-0033 See recall 2
- 68382-0095 Carvedilol 2
- 68382-0099 Paroxetine 2
- 68382-0110 Bromocriptine mesylate 2
- 68382-0123 Amlodipine Besylate 2
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