Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
National Drug Code
Is NDC 0597-0300-45 recalled?
Synjardy XR · 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0300-45)
Yes — this exact package was recalled
2 FDA recalls name the code 0597-0300-45 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.
1 of these recalls is still ongoing.
- Active ingredient
- empagliflozin, metformin hydrochloride
- Strength
- EMPAGLIFLOZIN 12.5 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1
- Form
- Tablet, Extended Release · Oral
- Labeler
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Type
- Human Prescription Drug
- Product code
- 0597-0300
Recalls naming this package
Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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.