Why it was recalled
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Product description
Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]
Lot numbers, UPCs & expiration codes
Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019
Where it was sold
Nationwide in the USA
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-0372-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 3, 2019
- FDA report date
- Jan 16, 2019
- Quantity
- 12,534 cartons, 125,340 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0372-2019, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81891
- Address
- 270 Prospect Plains Rd
- Code information
- Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019
- Postal code
- 08512-3605
- Report date
- Jan 16, 2019
- Product type
- Drugs
- Recall number
- D-0372-2019
- Classification
- Class I
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 12,534 cartons, 125,340 vials
- Termination date
- Nov 3, 2021
- Reason for recall
- Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 3, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 14, 2019