Aidapak Recalls GuaiFENesin ER Tablets Due to Labeling Mixup
Aidapak Services, LLC is recalling GuaiFENesin ER 600 mg tablets because they may be mislabeled as other prescription drugs.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no injuries are reported, the potential for mislabeling prescription drugs (like Misoprostol or Tacrolimus) as a different drug represents a significant risk of harm, fitting the Severe criteria for high-risk products where injury has not yet been reported but the hazard is substantial.
Plain-English summary
Aidapak Services, LLC is voluntarily recalling GuaiFENesin ER, Tablet, 600 mg, NDC 63824-0081-5, due to a labeling mixup. The recall involves 600-tablet units that were repacked and distributed in Arizona, California, Oregon, and Washington.
The source text indicates that the GuaiFENesin ER tablets may be potentially mislabeled as Misoprostol 200 mcg, Tacrolimus 1 mg, or Lactobacillus GG capsules. Specific pedigree codes and expiration dates are associated with the affected lots, including pedigrees AD21965_22, AD56917_13, AD73627_23, W003218, W003360, and W002660.
Consumers and healthcare providers should check their inventory for these specific NDC numbers and pedigree codes. If the product is found, it should be returned to the distributor or disposed of according to local regulations. The FDA has classified this as a Class II recall, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- guaiFENesin ER, Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000815
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 600
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 (14)
- guaiFENesin ER
- Tablet
- 600 mg has the following codes Pedigree: AD21965_22
- EXP: 5/1/2014
- Pedigree: AD56917_13
- EXP: 5/21/2014
- Pedigree: AD73627_23
- EXP: 5/30/2014
- Pedigree: W003218
- EXP: 6/17/2014
- Pedigree: W003360
- EXP: 6/19/2014
- Pedigree: W002660
- EXP: 6/5/2014.
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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