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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88392

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 29, 2021
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605

D-0721-2021
Recall number
D-0721-2021
Initiated
July 29, 2021
Classification
Class II
Status
Terminated
Quantity
a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of CGMP

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Code information

Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 2 of 3

Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08

D-0722-2021
Recall number
D-0722-2021
Initiated
July 29, 2021
Classification
Class II
Status
Terminated
Quantity
400 cases (12 bottles/case)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of CGMP

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Code information

Lot: C62F Exp. 31OCT2022

Distribution pattern

Distributed Nationwide in the USA

drug · product 3 of 3

Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16

D-0723-2021
Recall number
D-0723-2021
Initiated
July 29, 2021
Classification
Class II
Status
Terminated
Quantity
75 cases (6 bottles/case)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of CGMP

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Code information

Lot: C9BC Exp. 31OCT2022

Distribution pattern

Distributed Nationwide in the USA