D-1012-2023 Class II Terminated
FDA drug recall D-1012-2023 was initiated by Central Admixture Pharmacy Services, Inc. on July 14, 2023 and is designated Class II. Reason for recall: Lack of assurance of sterility. Validation data for decontamination cycles is lacking. The recall status is terminated (terminated March 28, 2025). Affected quantity: 33,073 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- August 9, 2023
- Initiation Date
- July 14, 2023
- Termination Date
- March 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,073 bags
Product Description
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
Reason for Recall
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Distribution Pattern
Nationwide in the USA
Code Information
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