Agency classClass IIOur severity:Severe FDA (Drugs)·D-0234-2018·Announced 2018-01-31

International Laboratories Recalls Pravastatin Sodium Tablets Due to Foreign Tablets

International Laboratories, Inc. is recalling Pravastatin Sodium Tablets, 20 mg, because bottles may contain 10 mg tablets. Patients should contact their healthcare provider.

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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (incorrect medication dosage) are classified as Severe (Score 4), as they are not explicitly Class I but involve significant risk.

Plain-English summary

International Laboratories, Inc. is recalling Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles. The recall involves 13,403 cartons of the medication, which is packaged for individual patient dispensing. The product is identified by Lot 117103A and an expiration date of 03/19.

The recall is being conducted because bottles may contain a mixture of pravastatin sodium 10 mg and 20 mg tablets. This presence of foreign tablets could result in patients receiving an incorrect dosage of the medication. The affected product was distributed nationwide in the USA.

Patients who have received this medication should contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16.
Manufacturer: International Laboratories, Inc.
Category: Drug — Prescription Medication
Hazard: foreign-object
dosage-error
Affected units: 13,403

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: 117103A
Exp. 03/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by International Laboratories, Inc. 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 2 products in this recall →

Same manufacturer · International Laboratories, Inc.

See all →

Severe
Pravastatin Sodium Tablets Recalled Due to Foreign Tablet Presence
FDA (Drugs) · 2018-01-31
Critical
Pravastatin Tablets Recalled Due to Incorrect Bupropion Filling
FDA (Drugs) · 2017-12-13

Same hazard · foreign object