Why it was recalled
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Product description
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
Lot numbers, UPCs & expiration codes
Lot #: 52610LL, Exp. 01 OCT 2016; Lot #: 57660LL, Exp. 01 MAR 2017
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-1359-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 23, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- 373,850 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1359-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74399
- Address
- 275 N Field Dr
- Code information
- Lot #: 52610LL, Exp. 01 OCT 2016; Lot #: 57660LL, Exp. 01 MAR 2017
- Postal code
- 60045-2579
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1359-2016
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 373,850 tubes
- Termination date
- Aug 31, 2018
- Reason for recall
- Crystallization: Product contains particulate identified to be crystallized active ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 23, 2016
- Initial firm notification
- Letter
- Center classification date
- Jul 12, 2016