Agency classClass IIOur severity:Moderate FDA (Drugs)·D-891-2014·Announced 2014-01-29

Aidapak Recalls Atropine Sulfate/Diphenoxylate Tablets Due to Label Mixup

Aidapak Services, LLC is recalling Atropine Sulfate/Diphenoxylate HCL tablets because they may have been mislabeled as Cyanocobalamin or Tri-Buffered Aspirin.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a labeling error that could result in temporary or medically reversible health consequences. The rubric aligns minor labeling errors and low-risk contamination with a Moderate severity score.

Plain-English summary

Aidapak Services, LLC is recalling Atropine Sulfate/Diphenoxylate HCL tablets, 0.025 mg/2.5 mg, NDC 00378041501. The recall is due to a labeling error where the product may have been mislabeled as Cyanocobalamin, Tablet, 1000 mcg, or Tri-Buffered Aspirin, Tablet, 325 mg.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. The recall involves two specific pedigree codes: AD65475_13 with an expiration date of 5/28/2014, and W003597 with an expiration date of 6/24/2014. The source text does not specify the total number of units recalled or the specific facilities where the products were distributed.

Consumers and healthcare providers should check their inventory for these specific NDC and pedigree codes. If the product is found, it should be returned to the distributor or the recalling firm, Aidapak Services, LLC. Patients should consult their healthcare provider if they have taken the medication and have concerns regarding the labeling.

The recalled product

Product: ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378041501.
Manufacturer: Aidapak Services, LLC
Category: Drug — Prescription Medication
Hazard: mis-labeling
Affected units: 300

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)

ATROPINE SULFATE/DIPHENOXYLATE HCL
Tablet
0.025 mg/2.5 mg has the following codes: Pedigree: AD65475_13
EXP: 5/28/2014
Pedigree: W003597
EXP: 6/24/2014.

Distribution

Distributed in 4 states:

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.

See all 265 products in this recall →

Same manufacturer · Aidapak Services, LLC

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Same hazard · mis labeling