Why it was recalled
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Product description
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
Lot numbers, UPCs & expiration codes
Lots# 03045 and 03046; Exp. 10/16
Where it was sold
Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
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-1480-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 29, 2016
- FDA report date
- Sep 14, 2016
- Quantity
- 274 multdose vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Isomeric Pharmacy Solution, LLC
Original FDA data
Every field from FDA enforcement report D-1480-2016, exactly as published.
Show all FDA fields
- City
- Salt Lake City
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 74603
- Address
- 2401 S Foothill Dr
- Code information
- Lots# 03045 and 03046; Exp. 10/16
- Postal code
- 84109-1479
- Report date
- Sep 14, 2016
- Product type
- Drugs
- Recall number
- D-1480-2016
- Classification
- Class II
- Recalling firm
- Isomeric Pharmacy Solution, LLC
- Product quantity
- 274 multdose vials
- Termination date
- Dec 20, 2016
- Reason for recall
- Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
- Distribution pattern
- Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.
- Recall initiation date
- Jun 29, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 2, 2016