Why it was recalled
Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: 117093A, Exp. 06/19
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0233-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 12, 2018
- FDA report date
- Jan 31, 2018
- Quantity
- 9,052 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- International Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0233-2018, exactly as published.
Show all FDA fields
- City
- Seminole
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 78939
- Address
- 6950 Bryan Dairy Rd Ste A
- Code information
- Lot: 117093A, Exp. 06/19
- Postal code
- 33777-1606
- Report date
- Jan 31, 2018
- Product type
- Drugs
- Recall number
- D-0233-2018
- Classification
- Class II
- Recalling firm
- International Laboratories, Inc.
- Product quantity
- 9,052 cartons
- Termination date
- May 1, 2019
- Reason for recall
- Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 12, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 24, 2018