Aidapak Recalls Lubiprostone Capsules Due to Potential Labeling Errors
Aidapak Services is recalling Lubiprostone capsules because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.
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 administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Lubiprostone Capsule, 24 mcg, NDC 64764024060, due to a labeling error. The repacked drug products may be potentially mislabeled as Aripiprazole Tablet, 2 mg, Cyanocobalamin Tablet, 1000 mcg, or Valsartan Tablet, 160 mg.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree codes and expiration dates of May 1, 2014, and May 16, 2014. The agency has classified this as a Class II recall.
Consumers and healthcare providers should check their inventory for the specific NDC and pedigree codes listed in the recall notice. If the product is found, it should be returned to the distributor or the FDA should be contacted for further instructions.
The recalled product
- Product
- LUBIPROSTONE Capsule, 24 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764024060
- 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)
- LUBIPROSTONE Capsule
- 24 mcg has the following codes Pedigree: AD21790_46
- EXP: 5/1/2014
- Pedigree: AD21811_1
- Pedigree: AD46312_1
- EXP: 5/16/2014.
Distribution
Part of a larger recall action
This product is one of 273 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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