Why it was recalled
Defective Container: Tamper Evident foil seal not completely intact.
Product description
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
Lot numbers, UPCs & expiration codes
Lot US1259
Where it was sold
U.S. 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-1042-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 38,280 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1042-2018, exactly as published.
Show all FDA fields
- City
- Morton Grove
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80386
- Address
- 6451 Main St
- Code information
- Lot US1259
- Postal code
- 60053-2633
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1042-2018
- Classification
- Class II
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Product quantity
- 38,280 bottles
- Termination date
- Sep 9, 2022
- Reason for recall
- Defective Container: Tamper Evident foil seal not completely intact.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jul 24, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2018