Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, I...

FDA Recall #D-0531-2020 — Class II — November 21, 2019

Recall #D-0531-2020 Date: November 21, 2019 Classification: Class II Status: Terminated

Product Description

Ibuprofen Oral Suspension USP, 100 mg/5mL, 4 fl.oz. 118 mL, Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA. Mfg: Taro Pharm.; Hawthorne, NY; NDC 68788-7268-01

Reason for Recall

Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Recalling Firm

Preferred Pharmaceuticals, Inc — Anaheim, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

CA, FL, IL

Code Information

Lot #: I1718U, Exp. 3/2020; K0818L, Exp. 9/2020; L2718E, Exp. 9/2020; A2219E, Exp. 9/2020; C1519S, Exp. 12/2020; C2819Y, Exp. 12/2020; E2019V, Exp. 11/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated