Aidapak Recalls Rosuvastatin Calcium Tablets Due to Labeling Error
Aidapak Services, LLC is recalling 5 mg rosuvastatin calcium tablets because they may have been mislabeled as ibuprofen or ascorbic acid.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly given the risk of patients receiving incorrect prescription medications.
Plain-English summary
Aidapak Services, LLC is recalling 180-count bottles of 5 mg rosuvastatin calcium tablets (NDC 00310075590) due to a labeling error. The recall involves specific lots with pedigree numbers W002567 (expiration 6/3/2014) and AD21811_10 (expiration 5/2/2014).
The FDA classified this as a Class II recall because the rosuvastatin tablets may have been mislabeled as either 400 mg ibuprofen tablets (NDC 67877029401) or 250 mg ascorbic acid tablets (NDC 00904052260). This mislabeling could result in patients receiving the wrong medication.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers should check their medication bottles for the affected NDC and pedigree numbers and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- ROSUVASTATIN CALCIUM, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00310075590.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 180
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)
- ROSUVASTATIN CALCIUM
- Tablet
- 5 mg has the following codes: Pedigree: W002567
- EXP: 6/3/2014
- Pedigree: AD21811_10
- EXP: 5/2/2014.
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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