FDA Recalls Mislabeled Bromocriptine Mesylate Tablets Distributed by Aidapak Services
Aidapak Services is recalling 2.5 mg Bromocriptine Mesylate tablets that may have been mislabeled as 200 mg Caffeine tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences are rated as Severe (4).
Plain-English summary
Aidapak Services, LLC is recalling 102 tablets of Bromocriptine Mesylate, 2.5 mg, NDC 00574010601. The recall is due to a labeling error where the product may have been mislabeled as Caffeine, 200 mg tablets, NDC 24385060173. The affected lot has pedigree W003754 and an expiration date of 6/26/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should check their inventory for the specific NDC and pedigree number listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Consumers should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574010601.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 102
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 (4)
- BROMOCRIPTINE MESYLATE
- Tablet
- 2.5 mg has the following codes: Pedigree: W003754
- EXP: 6/26/2014.
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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