FDA recall D-1062-2016

Product

Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an amber glass 473 mL (one pint) bottle with child-resistant screw closure, Rx only, Distributed by: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301, NDC 64980-0504-48

Reason for recall

Subpotency: product assayed and found OOS for cyproheptadine

Distribution

NJ

Key facts

Status

Terminated

Initiation date

2016-06-07

Report date

2016-07-13

Termination date

2017-02-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brockton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1062-2016