Agency classClass IIOur severity:Severe FDA (Drugs)·D-634-2014·Announced 2014-01-22

FDA Recalls Mislabeled Docusate Sodium Capsules Distributed by Aidapak Services

Aidapak Services is recalling 1,998 docusate sodium capsules that may be mislabeled as 250 mg or tizanidine HCl tablets.

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 FDA classified this as a Class II recall involving a labeling mixup that could result in patients receiving the wrong medication or dosage, which aligns with the rubric criterion for Severe severity (FDA Class II with potential for significant harm).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Docusate Sodium Capsules, 100 mg, distributed by Aidapak Services, LLC. The recall involves 1,998 capsules that may be potentially mislabeled as Docusate Sodium Capsules, 250 mg, or Tizanidine HCl Tablets, 2 mg. This labeling mixup creates a risk that patients may receive the wrong medication or dosage.

The affected products were repacked and distributed in Arizona, California, Oregon, and Washington. The recall includes two specific pedigree codes: AD37063_1 with an expiration date of May 13, 2014, and W002977 with an expiration date of June 11, 2014. The FDA has classified this as a Class II recall, indicating a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.

Consumers who have these products should check their medication labels for the NDC 57896040110 and the specific pedigree codes listed above. If the product matches the description, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on proper disposal or replacement.

The recalled product

Product: DOCUSATE SODIUM Capsule, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 57896040110
Manufacturer: Aidapak Services, LLC
Category: Drug — Over-the-Counter Medication
Hazard: mis-labeling
wrong-medication
Affected units: 1,998

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)

DOCUSATE SODIUM
Capsule
100 mg has the following codes Pedigree: AD37063_1
EXP: 5/13/2014
Pedigree: W002977
EXP: 6/11/2014.

Distribution

Distributed in 4 states:

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.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

See all →

Moderate
Aidapak Recalls Sennosides Tablets Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-29
Moderate
Levothyroxine Sodium Tablets Recalled for Potential Labeling Mixup
FDA (Drugs) · 2014-01-29
Moderate
Aidapak Recalls Mislabeled Pantoprazole Sodium DR Tablets
FDA (Drugs) · 2014-01-29
Moderate
Aidapak Recalls Nifedipine ER Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-29
Moderate
Simvastatin Tablets Recalled for Potential Labeling Error
FDA (Drugs) · 2014-01-29

Same hazard · mis labeling