Class II · Moderate risk
amneal Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
National Drug Code
Is NDC 65162-0178-09 recalled?
Metformin Hydrochloride · 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-09)
Yes — this exact package was recalled
1 FDA recall names the code 65162-0178-09 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.
4 of these recalls are still ongoing.
- Active ingredient
- Metformin Hydrochloride
- Strength
- METFORMIN HYDROCHLORIDE 500 mg/1
- Form
- Tablet, Extended Release · Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Type
- Human Prescription Drug
- Product code
- 65162-0178
Recalls naming this package
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
amneal Metformin Hydrochloride Extended-release Tablets
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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
- 65162-0212 Extended Phenytoin Sodium 3
- 65162-0253 See recall 2
- 65162-0668 See recall 2
- 65162-0754 Benazepril Hydrochloride 2
- 65162-0755 Divalproex Sodium 2
- 65162-0179 Metformin Hydrochloride 1
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