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Recall Observatory FDA recall evidence

Drug product

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.

D-1042-2018

July 24, 2018

Class II

Product summary

Firm
Morton Grove Pharmaceuticals, Inc.
Event
Event 80386
Status
Terminated
Classification
Class II
Quantity
38,280 bottles
Official record key
drug-enforcement:D-1042-2018

Official wording

Reason: Defective Container: Tamper Evident foil seal not completely intact.

Code information: Lot US1259

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Tamper Evident foil seal not completely intact.