Why it was recalled
Defective Container: There were customer complaints of cracked and leaking glass vials.
Product description
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
Lot numbers, UPCs & expiration codes
Lot #s: 43406DD, Exp 7/1/2016; 44255DD, Exp 8/1/2016
Where it was sold
Nationwide
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-0418-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 20, 2015
- FDA report date
- Sep 23, 2015
- Quantity
- 83,320 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0418-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71939
- Address
- 275 N Field Dr
- Code information
- Lot #s: 43406DD, Exp 7/1/2016; 44255DD, Exp 8/1/2016
- Postal code
- 60045-2579
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-0418-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 83,320 vials
- Termination date
- Apr 3, 2017
- Reason for recall
- Defective Container: There were customer complaints of cracked and leaking glass vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 20, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 15, 2015