D-0865-2018 Class III Terminated
FDA drug recall D-0865-2018 was initiated by Pharmaceutical Associates Inc on May 29, 2018 and is designated Class III. Reason for recall: Resuspension problems: Out of specification for appearance and resuspendability. The recall status is terminated (terminated January 13, 2020). Affected quantity: 275400 cups.
Recall Details
- Product Type
- Drugs
- Report Date
- June 13, 2018
- Initiation Date
- May 29, 2018
- Termination Date
- January 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 275400 cups
Product Description
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Reason for Recall
Resuspension problems: Out of specification for appearance and resuspendability.
Distribution Pattern
Nationwide
Code Information
Lot: B5B8 Exp. 07/2019