Greenville, SC, United States
Pharmaceutical Associates Inc recalls
2 recalls recorded since 2018, most recently on 14 January 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 14 January 2020
- Terminated
- 3 June 2021
- Reason
- Subpotent: Out of specification for assay at the 12-month time point.
- Distribution
- Distributed Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0824-2020
- Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Terminated Class III Drugs
- Recall started
- 29 May 2018
- Terminated
- 13 January 2020
- Reason
- Resuspension problems: Out of specification for appearance and resuspendability.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0865-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.