Recalls / Class II
Class IID-1012-2023
Product
oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
- Affected lot / code info
- Lot: 36-247353, Exp. 7/13/2023; 36-247260, 36-247261, 36-247262, Exp. 7/14/2023; 36-248215, 36-248218, 36-248222, Exp. 7/19/2023; 36-248861, 36-248862, 36-248863, 36-248865, Exp. 7/21/2023; 36-249513, 36-249514, 36-249659, 36-249693, Exp. 7/24/2023; 36-249661, 36-249662, 36-249663, 36-249664, 36-249665, Exp. 7/26/2023; 36-249750, 36-249754, 36-249755, 36-249756, 36-249757, Exp. 7/27/2023; 36-249995, 36-249996, 36-249997, 36-249999, 36-250001, 36-250003, 36-250230, Exp. 7/28/2023; 36-250424, 36-250425, 36-250426, 36-250427, 36-250428, 36-250429, Exp. 7/29/2023; 36-251374, 36-251375, 36-251376, 36-251377, 36-251378, 36-251379, 36-251380, 36-251381, 36-251382, Exp. 8/2/2023; 36-251438, 36-251441, 36-251442, Exp. 8/3/2023; 36-251799, 36-251801, 36-251802, 36-251803, 36-251805, 36-251806, 36-251804, Exp. 8/4/2023; 36-251993, 36-251995, 36-251996, Exp. 8/5/2023; 36-252202, Exp. 8/6/2023; 36-252470, 36-252474, 36-252476, 36-252477, 36-252478, Exp. 8/9/2023; 36-254387, 36-254388, 36-254389, 36-254390, 36-254391, 36-254392, 36-254393, 36-254398, 36-254399, Exp. 8/10/2023; 36-254666, 36-254807, Exp. 8/11/2023
Why it was recalled
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Recalling firm
- Firm
- Central Admixture Pharmacy Services, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909
Distribution
- Quantity
- 33,073 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-07-14
- FDA classified
- 2023-08-01
- Posted by FDA
- 2023-08-09
- Terminated
- 2025-03-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1012-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.