The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-628-2014·Announced 2014-01-22

Aidapak Recalls Metoprolol Tartrate Tablets Due to Labeling Mixup

Aidapak Services, LLC is recalling 402 Metoprolol Tartrate tablets because they may be mislabeled as Docusate Sodium capsules.

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 hazard is a labeling mixup between two different medications, which is a moderate risk.

Plain-English summary

Aidapak Services, LLC is recalling 402 tablets of Metoprolol Tartrate, 12.5 mg (1/2 of 25 mg), NDC 57664050652. The recall is due to a labeling mixup where the Metoprolol Tartrate tablets may be mislabeled as Docusate Sodium, Capsule, 250 mg, NDC 00904789159.

The affected Metoprolol Tartrate tablets have pedigree codes AD68010_14 and AD68010_17, with an expiration date of 5/28/2014. The potentially mislabeled Docusate Sodium capsules have pedigree code AD68022_1 and an expiration date of 5/28/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Consumers and healthcare providers should check their inventory for these specific pedigree codes and NDC numbers. If the products are found, they should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have taken the potentially mislabeled medication.

The recalled product

Product
METOPROLOL TARTRATE Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652
Affected units
402

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)

  • METOPROLOL TARTRATE
  • Tablet
  • 12.5 mg (1/2 of 25 mg) has the following codes Pedigree: AD68010_14
  • EXP: 5/28/2014
  • Pedigree: AD68010_17
  • EXP: 5/28/2014.

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

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