Aidapak Recalls Amantadine HCL Capsules Due to Labeling Mixup
Aidapak Services is recalling Amantadine HCL capsules because they may have been mislabeled as other prescription drugs.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling mixup that could lead to patients taking the wrong medication, which is a risk-of-harm scenario where injury has not yet been reported.
Plain-English summary
Aidapak Services, LLC is recalling Amantadine HCL, Capsule, 100 mg (NDC 00781204801) due to a labeling mixup. The recalled capsules may have been mislabeled as other prescription medications, including Acarbose, Clomipramine HCl, Aspirin EC DR, and Niacin TR.
The recalled product consists of 499-capsule bottles distributed in Arizona, California, Oregon, and Washington. The recall involves specific pedigree numbers with expiration dates ranging from February 2014 to June 2014.
Consumers should check their medication for the NDC 00781204801 and the pedigree numbers listed in the recall notice. If the medication matches the recalled product, consumers should contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781204801.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 499
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 (10)
- AMANTADINE HCL
- Capsule
- 100 mg has the following codes: Pedigree: W002726
- EXP: 6/6/2014
- Pedigree: W002997
- EXP: 6/11/2014
- Pedigree: W003674
- EXP: 6/25/2014
- Pedigree: W003323
- EXP: 6/18/2014.
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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