Why it was recalled
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Product description
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA 91730.
Lot numbers, UPCs & expiration codes
Lot #: a) B0158730-060816 (Mfg: XI002A6), Exp: 12/2017 ; and b) B0160669-061516 (Mfg: XI003A6), Exp 12/2017
Where it was sold
Product was distributed to one consignee in Louisiana.
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-1176-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 22, 2017
- FDA report date
- Oct 4, 2017
- Quantity
- 40 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-1176-2017, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 78146
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot #: a) B0158730-060816 (Mfg: XI002A6), Exp: 12/2017 ; and b) B0160669-061516 (Mfg: XI003A6), Exp 12/2017
- Postal code
- 15701-3571
- Report date
- Oct 4, 2017
- Product type
- Drugs
- Recall number
- D-1176-2017
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 40 vials
- Termination date
- Jan 3, 2018
- Reason for recall
- Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b) 10 x 1 mL vials per tray, NDC 61786-0741-08 (Orig: 00548-9021-00), Ref: 33632, Rx only, Packaged by: RemedyRepack Inc, Indiana, PA 15704; Mfg by: Amphastar, Rancho Cucamonga, CA 91730.
- Distribution pattern
- Product was distributed to one consignee in Louisiana.
- Recall initiation date
- Aug 22, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 22, 2017