FDA Recalls Hyoscyamine Sulfate Tablets Due to Potential Labeling Errors
Aidapak Services is recalling 909 tablets of Hyoscyamine Sulfate SL 0.125 mg 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 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of administering the wrong prescription medication.
Plain-English summary
Aidapak Services, LLC is recalling 909 tablets of Hyoscyamine Sulfate SL, 0.125 mg, because the medication may have been mislabeled as other prescription drugs. The recall is classified as FDA Class II.
The potentially mislabeled products were distributed in Arizona, California, Oregon, and Washington. The source text indicates the tablets may have been confused with guanFACINE HCl or CYCLOBENZAPRINE HCL, though the full list of potential mislabels is truncated in the provided record.
Consumers should check their medication labels and contact their pharmacist or healthcare provider if they have received Hyoscyamine Sulfate SL tablets that appear to be labeled as a different drug.
The recalled product
- Product
- HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574025001.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 909
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 (16)
- HYOSCYAMINE SULFATE SL
- Tablet
- 0.125 mg has the following codes: Pedigree: AD21790_19
- EXP: 5/1/2014
- Pedigree: AD46265_7
- EXP: 5/15/2014
- Pedigree: W003679
- EXP: 6/25/2014
- Pedigree: AD60272_16
- EXP: 5/22/2014
- Pedigree: AD30140_10
- EXP: 5/7/2014
- Pedigree: W003000
- EXP: 6/11/2014
- Pedigree: W003326
- EXP: 6/19/2014.
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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