Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
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.
Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Compare with the code on your package — it is the most precise check available.
Drug: Bromocriptine
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 |
|---|---|---|---|---|
| Bromocriptine mesylate NDC 68382-0110 |
5 mg/1 | Capsule Oral |
Zydus Pharmaceuticals USA Inc. | Rx |
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.
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD68010_1, EXP: 5/28/2014; THIORIDAZINE HCL, Tablet, 50 mg, NDC 00378061601, Pedigree: AD73525_28, EXP: 5/30/2014.
Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: W003725, EXP: 6/26/2014.
Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as the following drug: CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD32582_3, EXP: 5/9/2014.
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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