Class II · Moderate risk
Bromocriptine Mesylate Capsules
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
National Drug Code
Is NDC 68382-0110-06 recalled?
Bromocriptine mesylate · 30 CAPSULE in 1 BOTTLE (68382-110-06)
Yes — this exact package was recalled
2 FDA recalls name the code 68382-0110-06 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
1 of these recalls is still ongoing.
- Active ingredient
- Bromocriptine mesylate
- Strength
- BROMOCRIPTINE MESYLATE 5 mg/1
- Form
- Capsule · Oral
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Type
- Human Prescription Drug
- Product code
- 68382-0110
Recalls naming this package
Class II · Moderate risk
Bromocriptine Mesylate Capsules USP
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.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 68382-0021 Venlafaxine 2
- 68382-0033 See recall 2
- 68382-0095 Carvedilol 2
- 68382-0099 Paroxetine 2
- 68382-0123 Amlodipine Besylate 2
- 68382-0196 See recall 2
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