The Recall Desk
ModerateFDA (Drugs)·D-791-2014·Announced 2014-01-29

FDA Recalls Lithium Carbonate ER Tablets Due to Labeling Mixup

Aidapak Services, LLC is recalling Lithium Carbonate ER tablets because they may be mislabeled as Vitamin B Complex Prolonged Release tablets.

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 that might cause temporary or medically reversible adverse health consequences. The hazard is a labeling mixup, which fits the criteria for moderate severity.

Plain-English summary

Aidapak Services, LLC is recalling Lithium Carbonate ER, Tablet, 300 mg, NDC 00054002125, due to a labeling mixup. The recall involves 2,400 tablets with pedigree AD39564_1 and an expiration date of 5/13/2014.

The FDA has identified that the Lithium Carbonate ER tablets may be potentially mislabeled as Vitamin B Complex Prolonged Release, Tablet, 50 mg, NDC 40985022251. The mislabeled product shares the same expiration date of 5/13/2014 but has a different pedigree (AD39588_10).

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. 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 recalled product

Product
LITHIUM CARBONATE ER, Tablet, 300 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054002125.
Affected units
2,400

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 (4)

  • LITHIUM CARBONATE ER
  • Tablet
  • 300 mg has the following codes: Pedigree: AD39564_1
  • EXP: 5/13/2014.

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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