Hyoscyamine Sulfate Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling Hyoscyamine Sulfate tablets because they may be mislabeled as Azathioprine or Cholecalciferol.
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 significant harm (such as mislabeling a prescription drug as a different medication) fall under the Severe category.
Plain-English summary
Aidapak Services, LLC is recalling Hyoscyamine Sulfate SL Tablets, 0.125 mg, NDC 76439030910. The recall is due to a labeling mixup where these tablets may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, or CHOLECALCIFEROL, Tablet, 1000 units.
The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The specific lots involved include Pedigree AD54501_1 with an expiration date of 5/21/2014, and Pedigree W003438 with an expiration date of 6/20/2014.
Consumers and healthcare providers should check their inventory for these specific NDCs and pedigree codes. If the product is found, it should be returned to the distributor or disposed of according to local regulations to prevent accidental administration of the wrong medication.
The recalled product
- Product
- HYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 76439030910
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Affected units
- 200
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)
- HYOSCYAMINE SULFATE SL
- Tablet
- 0.125 mg has the following codes Pedigree: AD54501_1
- EXP: 5/21/2014
- Pedigree: W003438
- EXP: 6/20/2014.
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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