Agency classClass IIOur severity:Severe FDA (Drugs)·D-685-2013·Announced 2013-07-17

Fresenius Kabi Recalls Benztropine Mesylate Injection Due to Glass Particulates

Fresenius Kabi is recalling 65,110 vials of Benztropine Mesylate Injection due to the presence of glass particulate matter. The affected vials were distributed nationwide and in Puerto Rico.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as injection of glass particulates) are categorized as Severe (Score 4), particularly when no explicit 'no injury' statement is provided to lower the score to 3.

Plain-English summary

Fresenius Kabi USA, LLC is recalling 65,110 vials of Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial. The recall is due to the presence of particulate matter characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials.

The affected product is labeled as manufactured for APP Pharmaceuticals, LLC (NDC 63323-970-02) and Nexus Pharmaceuticals Inc. (NDC 14789-300-02). Specific lots affected include Lot 111412 (Exp: 11/2014) for APP Pharmaceuticals and Lots 030712 (Exp: 03/2014), 071212 (Exp: 07/2014), and 090512 (Exp: 09/2014) for Nexus Pharmaceuticals. The product was distributed nationwide and in Puerto Rico.

Healthcare providers and patients should discontinue use of the affected vials and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: BENZTROPINE MESYLATE (BENZTROPINE MESYLATE)
Brand: BENZTROPINE MESYLATE
Manufacturer: Fresenius Kabi USA, LLC
Category: Drug — Injection
Hazard: glass-particulate
injection-hazard
Affected units: 65,110

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 (7)

a) Lot: 111412
Exp: 11/2014 b) Lots: 030712
Exp: 03/2014
071212
Exp: 07/2014
090512
Exp: 09/2014

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Fresenius Kabi USA, LLC

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