The Recall Desk
SevereFDA (Drugs)·D-887-2014·Announced 2014-01-29

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.

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 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.
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

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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