Reported Jun 2, 2021 · Terminated
Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only…
Cardinal Health Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health Inc. · 7000 Cardinal Pl · Dublin, OH · 43017-1091
Is this the product you have?
- Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist
- byBoehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA
- Lot codes and dates
- 3190949
- Amount recalled
- 751 bottles
This recall covers 198 products
The agency filed one notice per product. You are reading one of them; the other 197 are below.
185 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
This product could cause temporary or reversible health problems — stop using it.
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