The Recall Desk
ModerateFDA (Drugs)·D-932-2014·Announced 2014-01-29

Aidapak Recalls Mislabeled Cyanocobalamin Tablets Due to Label Mixup

Aidapak Services, LLC is recalling 500 mcg Cyanocobalamin tablets that were mislabeled as Sevelamer Carbonate or other drugs. The recall covers products distributed in Arizona, California, Oregon, and Washington.

What this means for you

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 situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling mixup, which fits the criteria for moderate severity involving labeling errors.

Plain-English summary

Aidapak Services, LLC is recalling specific lots of CYANOCOBALAMIN, Tablet, 500 mcg, Over The Counter, NDC 00536355101. The recall is due to a labeling error where the product was mislabeled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001. The source text indicates the product may also have been mislabeled as VITAMIN B COMPLEX W/C, Tablet, or CYANOCOBALAMIN, Tablet, 1000 mcg.

The affected repacked drugs were distributed in Arizona, California, Oregon, and Washington. Specific pedigree codes and expiration dates are listed in the recall notice, including Pedigree W002860 with an expiration date of 6/7/2014, and Pedigree W002859 with an expiration date of 6/7/2014.

Consumers should check their medication labels against the specific NDC and pedigree codes provided in the official recall notice. If the product matches the recalled description, consumers should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

Product
CYANOCOBALAMIN, Tablet, 500 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536355101.
Affected units
700

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 (12)

  • CYANOCOBALAMIN
  • Tablet
  • 500 mcg has the following codes: Pedigree: AD52993_19
  • EXP: 5/20/2014
  • Pedigree: AD30180_25
  • EXP: 5/9/2014
  • Pedigree: AD37056_10
  • EXP: 5/10/2014
  • Pedigree: AD60578_16
  • EXP: 5/29/2014
  • Pedigree: W002860
  • EXP: 6/7/2014.

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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