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
This recall has been terminated (originally issued April 16, 2014).
- Recall Initiated
- December 12, 2013
- Posted
- April 16, 2014
- Recall Number
- D-1217-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 610 units
- Firm Location
- Mesa, AZ, United States
- Official Source
- View on FDA website ↗
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.
Distribution
AZ
Lot / Code Info
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