Status
Terminated
Drug Enforcement D-925-2013
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Classification
Class II
Report Date
September 4, 2013
Termination Date
February 8, 2016
Product Information
- Product description
- 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
- Product quantity
- 46,185 vials
- Reason for recall
- Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Nexus Pharmaceuticals Inc
- Address
-
175 E Hawthorn Pkwy Ste 155
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-925-2013
- Event ID
- 65853
- Recall initiation date
- August 1, 2013
- Center classification date
- August 27, 2013
- Code info
- a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14
- More code info
- —