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 tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured by: UNICHEM LABORATORIES, LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa, 403 511, India, Marketed by: UNICHEM PHARMACEUTICALS, (USA), INC. Hasbrouck Heights, NJ 07604, NDC 29300-126-13.
Affected NDC
29300-0126-13
Compare with the code on your package — it is the most precise check available.
Drug: Bisoprolol
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 NDC 29300-0126 |
5 mg/1 | Tablet Oral |
Unichem Pharmaceuticals (USA), Inc. | Rx |
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
- NDC code
- 29300-126-13
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0010-2018 · 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 Bisoprolol 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 III · Low risk
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Zebeta¿ (bisoprolol fumarate)
Failed Dissolution Specifications: OOS result during stability testing
Other recalls by Unichem Pharmaceuticals Usa Inc
All 2017 recalls
Class III · Low risk
busPIRone Hydrochloride Tablets
Subpotent drug
Class III · Low risk
Doxazosin Tablets
Tablets/Capsules Imprinted with Wrong ID
Class II · Moderate risk
Bisoprolol Fumarate and Hydrochlorothiazide tablets
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Class I · High risk
Cyclobenzaprine Hydrochloride Tablets
Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color).
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