Why it was recalled
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Product description
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 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 #: US1450, Exp 10/31/19; US1570, Exp 12/31/19; UT1018, Exp 1/31/19; UT1173, Exp 6/30/20; UT1348, UT1354, Exp 8/31/20
Where it was sold
Nationwide USA and Puerto Rico
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-0130-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 23, 2019
- FDA report date
- Oct 16, 2019
- Quantity
- 196,408 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0130-2020, exactly as published.
Show all FDA fields
- City
- Morton Grove
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 83858
- Address
- 6451 Main St
- Code information
- Lot #: US1450, Exp 10/31/19; US1570, Exp 12/31/19; UT1018, Exp 1/31/19; UT1173, Exp 6/30/20; UT1348, UT1354, Exp 8/31/20
- Postal code
- 60053-2633
- Report date
- Oct 16, 2019
- Product type
- Drugs
- Recall number
- D-0130-2020
- Classification
- Class II
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- Product quantity
- 196,408 bottles
- Termination date
- Sep 24, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Sep 23, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 8, 2019