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
Product summary
- 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
Out of specification