FDA-Drug2016-02-17Class II

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.

Safecor Health, LLC
Hazard

Defective Container: Confirmed customer complaints of leaking bottles.

Sold states
NJ
Affected count
3,532 amber bottles
Manufactured in
317 New Boston St, N/A, Woburn, MA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0661-2016

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