Class II · Moderate risk
Bisoprolol Fumarate and Hydrochlorothiazide tablets
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS
Affected NDC
0093-3241-01
Compare with the code on your package — it is the most precise check available.
Drug: Hydrochlorothiazide Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| bisoprolol fumarate and hydrochlorothiazide NDC 00093-3241 |
BISOPROLOL FUMARATE 2.5 mg/1; HYDROCHLOROTHIAZIDE 6.25 mg/1 | Tablet, Film Coated Oral |
Teva Pharmaceuticals USA, Inc. | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 0093-3241-01
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0575-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydrochlorothiazide recalls
See all
Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class II · Moderate risk
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Class II · Moderate risk
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Class III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Failed Impurities/Degradation Specifications
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
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Class II · Moderate risk
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CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
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CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
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CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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