Product Detail

Product Description Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.

Recall Number D-804-2013

Classification Class II

Code Info Lot #: 6003648, Exp. 6/2013

Product Distributed Qty 221,600 vials

Reason For Recall Subpotent Drug; The firm recalled one lot of Oxytocin Inj
(Synthetic) due to and Out-of-specification (OOS) result (85.6%) for assay at the 15-month stability test station. The specification is 90.0 % - 110.0%.

Event Detail

Event Id 65512

Product Type Drugs

Status Ongoing

Recalling Firm

Fresenius Kabi USA, LLC

City Lake Zurich
State IL
Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-06-24

Initial Firm Notification of Consignee or Public Letter

Distribution Pattern Nationwide and Puerto Rico