FDA recall D-1416-2012

Product

Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.

Reason for recall

Impurities/Degradation Products: exceeded specification at 3 month stability testing

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-05-30

Report date

2012-07-18

Termination date

2013-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1416-2012