The Recall Desk
SevereFDA (Drugs)·D-925-2013·Announced 2013-09-04

Nexus Pharmaceuticals Recalls Benztropine Mesylate Injection Due to Glass Particulates

Nexus Pharmaceuticals is recalling 46,185 vials of Benztropine Mesylate Injection due to the presence of glass delamination flakes.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a structural defect (glass delamination) that poses a risk of injury is classified as Severe.

Plain-English summary

Nexus Pharmaceuticals Inc is voluntarily recalling 46,185 vials of Benztropine Mesylate Injection, USP, 2 mg/mL, 2 mL Single Dose Vial. The recall affects two specific lots: Lot 112911 (Exp. 11/13) and Lot 030712 (Exp. 3/14). The product was distributed nationwide.

The recall was initiated because of the presence of particulate matter in the vials. This particulate matter is characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.

Patients and healthcare providers should stop using the affected vials and contact their healthcare provider for further instructions. The recalled product is prescription-only.

The recalled product

Product
Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02
Manufacturer
Nexus Pharmaceuticals Inc
Category
Drug — Injection
Hazard
Affected units
46,185

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • a) Lot: 112911
  • Exp. 11/13
  • b) Lot: 030712
  • Exp. 3/14

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · glass delamination

See all →