Why it was recalled
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
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
Lot numbers, UPCs & expiration codes
a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-925-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 1, 2013
- FDA report date
- Sep 4, 2013
- Quantity
- 46,185 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nexus Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-925-2013, exactly as published.
Show all FDA fields
- City
- Vernon Hills
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65853
- Address
- 175 E Hawthorn Pkwy Ste 155
- Code information
- a) Lot: 112911, Exp. 11/13, b) Lot: 030712, Exp. 3/14
- Postal code
- 60061-1493
- Report date
- Sep 4, 2013
- Product type
- Drugs
- Recall number
- D-925-2013
- Classification
- Class II
- Recalling firm
- Nexus Pharmaceuticals Inc
- Product quantity
- 46,185 vials
- Termination date
- Feb 8, 2016
- Reason for recall
- Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 1, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 27, 2013