Why it was recalled
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Product description
CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801
Lot numbers, UPCs & expiration codes
Lot number: JD-BP-37-20150801
Where it was sold
Distributed to MS and Spain
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-0486-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 18, 2018
- FDA report date
- Feb 20, 2019
- Quantity
- 205 grams
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LGM Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0486-2019, exactly as published.
Show all FDA fields
- City
- Erlanger
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 81790
- Address
- 2758 Circleport Dr
- Code information
- Lot number: JD-BP-37-20150801
- Postal code
- 41018-1079
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0486-2019
- Classification
- Class II
- Recalling firm
- LGM Pharma LLC
- Product quantity
- 205 grams
- Termination date
- Jun 9, 2023
- Reason for recall
- CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801
- Distribution pattern
- Distributed to MS and Spain
- Recall initiation date
- Dec 18, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 11, 2019