The Recall Desk
ModerateFDA (Drugs)·D-1086-2014·Announced 2014-03-05

Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence

Ranbaxy Inc. is recalling 64,626 bottles of Atorvastatin Calcium 10 mg tablets because a 20 mg tablet was found inside a sealed 10 mg bottle.

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 health consequences. The presence of a foreign tablet of a different strength represents a potential dosing error risk, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Ranbaxy Inc. is recalling 64,626 bottles of Atorvastatin Calcium Tablets, 10 mg, 90-count, Rx only. The recall was initiated after a pharmacist reported finding an Atorvastatin 20 mg tablet inside a sealed bottle of 90-count Atorvastatin 10 mg tablets.

The affected product is identified by NDC 63304-827-90 and lot codes 2407255 and 2407256, with an expiration date of 05/14. The product was distributed nationwide. The manufacturer is Ranbaxy Pharmaceuticals Inc., Jacksonville, FL, and it was manufactured by Ranbaxy Laboratories Ltd., New Delhi, India.

Consumers and healthcare providers should check their inventory for the specific lot codes and expiration date listed above. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund. Patients should consult their healthcare provider if they have questions regarding their medication.

The recalled product

Product
ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand
ATORVASTATIN CALCIUM
Manufacturer
Ranbaxy Inc.
Affected units
64,626

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 (2)

  • 2407255
  • 2407256 Exp. 05/14

UPCs (1)

  • 633048279024

Distribution

Distributed nationwide across the United States.