FDA Recalls Bromocriptine Mesylate Tablets Due to Potential Label Mixup
Aidapak Services, LLC is recalling 2.5 mg Bromocriptine Mesylate tablets because they may have been mislabeled as Benazepril HCl or Thioridazine HCl.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classifies this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly given the risk of patients receiving incorrect medications.
Plain-English summary
Aidapak Services, LLC is recalling specific lots of Bromocriptine Mesylate, 2.5 mg tablets. The recall is due to a labeling error where the medication may have been mislabeled as Benazepril HCl, 40 mg tablets or Thioridazine HCl, 50 mg tablets.
The affected product is identified by NDC 00574010603 and includes two specific pedigree codes: AD68010_4 with an expiration date of 5/28/2014, and AD73525_40 with an expiration date of 5/30/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Patients and healthcare providers should check their medication labels and contact their pharmacist or prescriber if they have received these specific lots. The FDA classifies this as a Class II recall, indicating a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574010603.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 63
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- BROMOCRIPTINE MESYLATE
- Tablet
- 2.5 mg has the following codes: Pedigree: AD68010_4
- EXP: 5/28/2014
- Pedigree: AD73525_40
- EXP: 5/30/2014.
Distribution
Part of a larger recall action
This product is one of 265 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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