Why it was recalled
cGMP deviations: Temperature abuse
Product description
MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0051-01) b) 25-count box (NDC 0703-0051-04), Rx only, MFG: Teva Pharma USA
Lot numbers, UPCs & expiration codes
McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Where it was sold
USA 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-1073-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 13, 2022
- FDA report date
- Jun 15, 2022
- Quantity
- 1088 cartons/1 vial each and 63 cartons/25 vials each
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
Original FDA data
Every field from FDA enforcement report D-1073-2022, exactly as published.
Show all FDA fields
- City
- Richmond
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 89646
- Address
- 9954 Maryland Drive
- Address (line 2)
- Deep Run Iii Ste. 4000
- Code information
- McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
- Postal code
- 23233
- Report date
- Jun 15, 2022
- Product type
- Drugs
- Recall number
- D-1073-2022
- Classification
- Class II
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product quantity
- 1088 cartons/1 vial each and 63 cartons/25 vials each
- Termination date
- Nov 30, 2023
- Reason for recall
- cGMP deviations: Temperature abuse
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0051-01) b) 25-count box (NDC 0703-0051-04), Rx only, MFG: Teva Pharma USA
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Apr 13, 2022
- Initial firm notification
- Letter
- Center classification date
- Jun 9, 2022