Agency classClass IIOur severity:Severe FDA (Drugs)·D-060-2013·Announced 2012-11-28

Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence

Ranbaxy Inc. is recalling 32,208 bottles of Atorvastatin Calcium 10 mg tablets because a 20 mg tablet was found inside a sealed 10 mg bottle.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential dosage errors that could lead to adverse health consequences.

Plain-English summary

Ranbaxy Inc. is recalling 32,208 bottles of Atorvastatin Calcium Tablets, 10 mg, 90-count. The recall was initiated after a pharmacist reported finding an Atorvastatin 20 mg tablet inside a sealed bottle of 10 mg tablets. The affected product is identified by Lot # 2407258 and an expiration date of 05/14.

The product was distributed nationwide. The FDA has classified this recall as Class II, indicating a situation in which use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled description, they should stop using it and contact their pharmacist or healthcare provider for guidance on obtaining a replacement.

The recalled product

Product: ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
Brand: ATORVASTATIN CALCIUM
Manufacturer: Ranbaxy Inc.
Category: Drug — Prescription Medication
Hazard: foreign-object
dosage-error
Affected units: 32,208

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)

Lot #: 2407258
Exp 05/14

Distribution

Distributed nationwide across the United States.

Same brand · ATORVASTATIN CALCIUM

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Same manufacturer · Ranbaxy Inc.

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Same hazard · foreign object