Why it was recalled
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Product description
Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH
Lot numbers, UPCs & expiration codes
Lots 186509 and 186982, exp 6/30/2021
Where it was sold
Nationwide
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-1847-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 27, 2019
- FDA report date
- Sep 18, 2019
- Quantity
- 60 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1847-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 83672
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lots 186509 and 186982, exp 6/30/2021
- Postal code
- 43217-1188
- Report date
- Sep 18, 2019
- Product type
- Drugs
- Recall number
- D-1847-2019
- Classification
- Class III
- Recalling firm
- American Health Packaging
- Product quantity
- 60 cartons
- Termination date
- Sep 9, 2020
- Reason for recall
- Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 27, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 6, 2019