FDA recall D-1416-2015

Silarx Pharmaceutical, Inc. · Class III · drug

Product

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-08-21
Report date: 2015-09-09
Termination date: 2015-12-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Carmel, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1416-2015