Why it was recalled
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Product description
Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
Lot numbers, UPCs & expiration codes
a) Lot #: 117460@5 Expiration Date: 12/12/2013, Lot #: 117911@5 Expiration Date: 12/19/2013, Lot #: 118301@9 Expiration Date: 12/25/2013 b) Lot #: 117462@6 Expiration Date: 12/12/2013, Lot #: 117916@6 Expiration Date: 12/19/2013, Lot #: 118305@10 Expiration Date: 12/25/2013 c) Lot #: 118011@23 Expiration Date: 12/18/2013, Lot #: 118092@63 Expiration Date: 12/18/2013, Lot #: 118401@31 Expiration Date: 12/25/2013, Lot #: 118013@24 Expiration Date: 12/18/2013, Lot #: 118094@64 Expiration Date: 12/18/2013, Lot #: 118403@32 Expiration Date: 12/25/2013
Where it was sold
AZ
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-1217-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 12, 2013
- FDA report date
- Apr 16, 2014
- Quantity
- 610 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
Original FDA data
Every field from FDA enforcement report D-1217-2014, exactly as published.
Show all FDA fields
- City
- Mesa
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 67080
- Address
- 5949 E University Dr
- Code information
- a) Lot #: 117460@5 Expiration Date: 12/12/2013, Lot #: 117911@5 Expiration Date: 12/19/2013, Lot #: 118301@9 Expiration Date: 12/25/2013 b) Lot #: 117462@6 Expiration Date: 12/12/2013, Lot #: 117916@6 Expiration Date: 12/19/2013, Lot #: 118305@10 Expiration Date: 12/25/2013 c) Lot #: 118011@23 Expiration Date: 12/18/2013, Lot #: 118092@63 Expiration Date: 12/18/2013, Lot #: 118401@31 Expiration Date: 12/25/2013, Lot #: 118013@24 Expiration Date: 12/18/2013, Lot #: 118094@64 Expiration Date: 12/18/2013, Lot #: 118403@32 Expiration Date: 12/25/2013
- Postal code
- 85205-7435
- Report date
- Apr 16, 2014
- Product type
- Drugs
- Recall number
- D-1217-2014
- Classification
- Class II
- Recalling firm
- Zions RX Formulations Services LLC dba RX Formuations Serv.
- Product quantity
- 610 units
- Termination date
- May 1, 2014
- Reason for recall
- Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205
- Distribution pattern
- AZ
- Recall initiation date
- Dec 12, 2013
- Initial firm notification
- Center classification date
- Apr 7, 2014