Aidapak Recalls Mislabeled Pantoprazole Sodium Tablets
Aidapak Services, LLC is recalling 20 mg pantoprazole sodium tablets that may be mislabeled as nortriptyline hydrochloride capsules.
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 90-count bottles of 20 mg pantoprazole sodium tablets (NDC 13668009690) due to a labeling error. The product, identified by pedigree W003695 and expiration date 6/26/2014, may be mislabeled as 75 mg nortriptyline hydrochloride capsules (NDC 00093081301, pedigree W003694).
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as FDA Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers should check their medication for the specific NDC and pedigree numbers listed above. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance on appropriate alternatives.
The recalled product
- Product
- PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009690
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 90
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)
- PANTOPRAZOLE SODIUM DR
- Tablet
- 20 mg has the following code Pedigree: W003695
- EXP: 6/26/2014.
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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