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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92407

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

Open FDA event record

Event summary

Timeline bucket
June 23, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Kramer Laboratories, 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

2 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 2

Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807

D-0942-2023
Recall number
D-0942-2023
Initiated
June 23, 2023
Classification
Class II
Status
Terminated
Recalling firm
Kramer Laboratories, Inc.
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Code information

Lot #: 8753, 8753A, Exp. Date 10/2023 Lot #: 8659 Exp. Date 8/2023

Distribution pattern

nationwide within the United States

drug · product 2 of 2

Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807

D-0943-2023
Recall number
D-0943-2023
Initiated
June 23, 2023
Classification
Class II
Status
Terminated
Recalling firm
Kramer Laboratories, Inc.
Quantity
N/A

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

Code information

Lot #: 8639, Exp. Date 8/2023

Distribution pattern

nationwide within the United States