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Recall Observatory FDA recall evidence

Drug product

Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01

D-0278-2022

November 29, 2021

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 89143
Status
Ongoing
Classification
Class II
Quantity
72 bottles
Official record key
drug-enforcement:D-0278-2022

Official wording

Reason: Defective container: Out of specification for container integrity leading to bottles leaking.

Code information: Lot #: E1220B

Distribution pattern: Distributed to 5 physician consignees located in the following states: CT, FL, and KS.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification