Pravastatin Sodium Tablets Recalled Due to Foreign Tablet Presence
International Laboratories, Inc. is recalling Pravastatin Sodium Tablets 10 mg because bottles may contain 20 mg tablets.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential significant injury or health risk.
Plain-English summary
International Laboratories, Inc. is recalling Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles. The recall involves 9,052 cartons of the product, which is packaged for individual patient dispensing per pharmacy dispenser cartons. The product is prescription-only and was distributed nationwide in the USA.
The recall was initiated due to the presence of foreign tablets. Specifically, bottles intended to contain only 10 mg pravastatin sodium tablets may also contain 20 mg pravastatin sodium tablets. The affected lot number is 117093A, with an expiration date of 06/19.
Patients and healthcare providers should check their inventory for this specific lot and NDC number (54458-927-16). If the product is found, it should be returned to the pharmacy or healthcare provider for disposal or replacement. Consumers should not take the medication if they suspect it is from the affected lot and should consult their healthcare provider for alternative treatment options.
The recalled product
- Product
- Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16.
- Manufacturer
- International Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 9,052
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: 117093A
- Exp. 06/19
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 →Related recalls
Same manufacturer · International Laboratories, Inc.
See all →- SevereInternational Laboratories Recalls Pravastatin Sodium Tablets Due to Foreign Tablets
FDA (Drugs) · 2018-01-31
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