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.

FDA recall notice · announced February 17, 2016 · Safecor Health

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

Defective Container: Confirmed customer complaints of leaking bottles.

Notes

Distribution: NJ
Lot/code information: Lot #846881; Exp 01/16
Quantity: 3,532 amber bottles
Status: Terminated
Products in this recall event:
- 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- (D-0661-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.