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Drug recall · FDA · Published January 12, 2018

International Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing

Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

🇺🇸 FDA recall #D-0233-2018DrugInternational Laboratories, Inc. ›
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Recalling firmInternational Laboratories, Inc.6950 Bryan Dairy Rd Ste A, N/A · Seminole, FL 33777-1606
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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Source Page by GovInfoNow · govinfonow.com/recall/40933-international-laboratories-inc-recalls-pravastatin-sodium-tablets-usp-10-mg · Recall date January 12, 2018 · FDA enforcement record: FDA #D-0233-2018

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“International Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing.” GovInfoNow, recall dated January 12, 2018. https://govinfonow.com/recall/40933-international-laboratories-inc-recalls-pravastatin-sodium-tablets-usp-10-mg. Based on FDA recall #D-0233-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0233-2018%22&limit=1).

How to tell if you have this one

  • Brand
    International Laboratories, Inc.
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide in the USA
Recall numberProduct, codes & lotsQuantity
D-0233-2018Pravastatin 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.; Lot: 117093A, Exp. 06/199,052 cartons
D-0234-2018Pravastatin 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.; Lot: 117103A, Exp. 03/1913,403 cartons
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Contact International Laboratories, Inc.

We’ve drafted a message you can send International Laboratories, Inc. to request your refund or repair — edit it as you like.

Subject: Recall D-0233-2018 — International Laboratories, Inc. International Laboratories, Inc. recalls Pravastatin Sodium Tablet

Hello,

I own a International Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing that is covered by recall D-0233-2018 from International Laboratories, Inc..

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0233-2018 (January 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0233-2018 to see it in context.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA