Why it was recalled
Crystallization
Product description
Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
Lot numbers, UPCs & expiration codes
Lots 35-231-DK, 35-235-DK, 35-507-DK Exp. Date 1NOV2015; Lot 36-136-DK Exp. Date 1DEC2015; Lot 37-146-DK Exp. Date 1JAN2016; Lot 38-138-DK Exp. Date 1FEB2016; Lots 39-103-DK, 39-255-DK Exp. Date 1MAR2016; Lots 40-539-DK, 40-549-DK, Exp. Date 1APR2016; Lot 41-079-DK Exp. Date 1MAY2016; Lots 42-252-DK, 42-254-DK Exp. Date 1JUN2016; Lots 43-262-DK, 43-263-DK Exp. Date 1JUL2016; Lots 45-031-DK, 45-032-DK, 45-033-DK Exp. Date 1SEP2016; Lot 46-001-DK Exp. 1OCT2016 - Note: The lot number may be followed by additional numbers from 01 to 99 NOVAPLUS label Lot 35-230-DK Exp. Date 1NOV2015; Lot 40-535-DK Exp. Date 1APR2016 - Note: The lot number may be followed by additional numbers from 01 to 99
Where it was sold
Nationwide, Puerto Rico and Guam.
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-0972-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 13, 2015
- FDA report date
- May 6, 2015
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0972-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71002
- Address
- 600 N Field Dr
- Code information
- Lots 35-231-DK, 35-235-DK, 35-507-DK Exp. Date 1NOV2015; Lot 36-136-DK Exp. Date 1DEC2015; Lot 37-146-DK Exp. Date 1JAN2016; Lot 38-138-DK Exp. Date 1FEB2016; Lots 39-103-DK, 39-255-DK Exp. Date 1MAR2016; Lots 40-539-DK, 40-549-DK, Exp. Date 1APR2016; Lot 41-079-DK Exp. Date 1MAY2016; Lots 42-252-DK, 42-254-DK Exp. Date 1JUN2016; Lots 43-262-DK, 43-263-DK Exp. Date 1JUL2016; Lots 45-031-DK, 45-032-DK, 45-033-DK Exp. Date 1SEP2016; Lot 46-001-DK Exp. 1OCT2016 - Note: The lot number may be followed by additional numbers from 01 to 99 NOVAPLUS label Lot 35-230-DK Exp. Date 1NOV2015; Lot 40-535-DK Exp. Date 1APR2016 - Note: The lot number may be followed by additional numbers from 01 to 99
- Postal code
- 60045-4835
- Report date
- May 6, 2015
- Product type
- Drugs
- Recall number
- D-0972-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Termination date
- Dec 4, 2017
- Reason for recall
- Crystallization
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
- Distribution pattern
- Nationwide, Puerto Rico and Guam.
- Recall initiation date
- Apr 13, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2015