Drug product
Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA, Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04
D-0457-2020
Product summary
- Event
- Event 83265
- Status
- Completed
- Classification
- Class II
- Quantity
- 90,072 units
- Official record key
drug-enforcement:D-0457-2020
Official wording
Reason: Lack of Assurance of Sterility
Code information: 16250 09/19 17088 03/20 17307 10/20 17323 10/20 18014 1/21 18228 9/21 18261 10/21 19119 4/22
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility