FDA recall D-510-2013

Product

AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.

Reason for recall

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Distribution

FL, MS, SC, LA and TX

Key facts

Status

Terminated

Initiation date

2013-01-30

Report date

2013-06-12

Termination date

2016-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brooksville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-510-2013