Why it was recalled
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Product description
Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
Lot numbers, UPCs & expiration codes
038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
Where it was sold
Nationwide within the United States
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-0658-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 17, 2019
- FDA report date
- Jan 22, 2020
- Quantity
- 25,817 shelf packs/25 vials per pack
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0658-2020, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84534
- Address
- 2 Esterbrook Ln
- Code information
- 038368, Exp. Mar 2020; 058314, Exp. May 2020; 078305, 078307, Exp. July 2020; 118362 Exp. Nov 2020
- Postal code
- 08003-4002
- Report date
- Jan 22, 2020
- Product type
- Drugs
- Recall number
- D-0658-2020
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 25,817 shelf packs/25 vials per pack
- Termination date
- Jun 9, 2021
- Reason for recall
- Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL Single Dose Vials (NDC 0641-6043-01), 25 vials/shelf-pack (NDC 0641-6043-25), For IM Use Only, Rx only, Manufactured by: WEST-WARD Eatontown, NJ 07724 USA.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 17, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2020