Why it was recalled
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Product description
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Lot numbers, UPCs & expiration codes
Lot: 04252017@1, exp 5/9/2018
Where it was sold
TX, LA, PA, MA, FL, and OH
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-0012-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 25, 2017
- FDA report date
- Oct 25, 2017
- Quantity
- 945 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RXQ Compounding LLC
Original FDA data
Every field from FDA enforcement report D-0012-2018, exactly as published.
Show all FDA fields
- City
- Athens
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 78175
- Address
- 340 W State St Unit 9
- Code information
- Lot: 04252017@1, exp 5/9/2018
- Postal code
- 45701-1564
- Report date
- Oct 25, 2017
- Product type
- Drugs
- Recall number
- D-0012-2018
- Classification
- Class II
- Recalling firm
- RXQ Compounding LLC
- Product quantity
- 945 vials
- Termination date
- Dec 6, 2017
- Reason for recall
- Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
- Distribution pattern
- TX, LA, PA, MA, FL, and OH
- Recall initiation date
- Sep 25, 2017
- Initial firm notification
- Telephone
- Center classification date
- Oct 18, 2017