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.
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. 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
- 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
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