Drug product
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
D-0661-2016
Product summary
- Event
- Event 72947
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,532 amber bottles
- Official record key
drug-enforcement:D-0661-2016
Official wording
Reason: Defective Container: Confirmed customer complaints of leaking bottles.
Code information: Lot #846881; Exp 01/16
Distribution pattern: NJ
Derived failure modes
-
Unknown
Defective Container: Confirmed customer complaints of leaking bottles.