Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Perindopril Erbumine Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
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
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Affected NDC
0054-0112-25
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- NDC code
- 0054-0112-25
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-126-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Boehringer Ingelheim Roxane Inc
All 2012 recalls
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class II · Moderate risk
Combivent Respimat
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Class II · Moderate risk
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
Other impurity / degradation recalls from 2012
All impurity / degradation recalls
Class III · Low risk
Femtrace 0.45 mg
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Class III · Low risk
Femtrace 0.9 mg
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Class III · Low risk
Caziant (desogestrel and ethinyl estradiol)
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Class II · Moderate risk
Temodar (temozolomide)
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
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