Why it was recalled
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
Product description
Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
Lot numbers, UPCs & expiration codes
Lot # B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020
Where it was sold
Product distributed in OK and LA.
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-0867-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 27, 2019
- FDA report date
- Feb 19, 2020
- Quantity
- 75 1 ml vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0867-2020, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 84900
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot # B0444562-060118, exp. 04/2020, B0537002-112118, exp 07/2020
- Postal code
- 15701-3571
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0867-2020
- Classification
- Class I
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 75 1 ml vials
- Termination date
- Aug 18, 2020
- Reason for recall
- Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00
- Distribution pattern
- Product distributed in OK and LA.
- Recall initiation date
- Dec 27, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2020