Why it was recalled
Lack of Assurance of Sterility
Product description
L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
Texas
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-0531-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 10, 2015
- FDA report date
- Jan 6, 2016
- Quantity
- 14 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Walgreens Infusion Services
Original FDA data
Every field from FDA enforcement report D-0531-2016, exactly as published.
Show all FDA fields
- City
- San Antonio
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 72594
- Address
- 14220 Northbrook Dr Ste 100B
- Code information
- All lots within expiry.
- Postal code
- 78232-5045
- Report date
- Jan 6, 2016
- Product type
- Drugs
- Recall number
- D-0531-2016
- Classification
- Class II
- Recalling firm
- Walgreens Infusion Services
- Product quantity
- 14 syringes
- Termination date
- Oct 18, 2017
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
- Distribution pattern
- Texas
- Recall initiation date
- Nov 10, 2015
- Initial firm notification
- Letter
- Center classification date
- Dec 30, 2015