Why it was recalled
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Product description
Naltrexone 4.5 mg capsule
Lot numbers, UPCs & expiration codes
Lot: 60564:42 Use by: 02/10/2020
Where it was sold
TX
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-0810-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 18, 2019
- FDA report date
- Feb 5, 2020
- Quantity
- 2 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MPRX, Inc. dba Medical Park Pharmacy
Original FDA data
Every field from FDA enforcement report D-0810-2020, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 84527
- Address
- 8230 Elmbrook Dr Ste 600b
- Code information
- Lot: 60564:42 Use by: 02/10/2020
- Postal code
- 75247-4144
- Report date
- Feb 5, 2020
- Product type
- Drugs
- Recall number
- D-0810-2020
- Classification
- Class II
- Recalling firm
- MPRX, Inc. dba Medical Park Pharmacy
- Product quantity
- 2 bottles
- Termination date
- Dec 13, 2022
- Reason for recall
- Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Naltrexone 4.5 mg capsule
- Distribution pattern
- TX
- Recall initiation date
- Dec 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 29, 2020