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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77869

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

Open FDA event record

Event summary

Timeline bucket
August 02, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
The Harvard Drug Group

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

5 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 5

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85

D-1119-2017
Recall number
D-1119-2017
Initiated
August 02, 2017
Classification
Class II
Status
Terminated
Recalling firm
The Harvard Drug Group
Quantity
7,308 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Code information

Item# 370010, Lot: 20351701

Distribution pattern

Nationwide in the USA

drug · product 2 of 5

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85

D-1120-2017
Recall number
D-1120-2017
Initiated
August 02, 2017
Classification
Class II
Status
Terminated
Recalling firm
The Harvard Drug Group
Quantity
7,272 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Code information

Item# 370282, Lot: 22941701

Distribution pattern

Nationwide in the USA

drug · product 3 of 5

Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09

D-1121-2017
Recall number
D-1121-2017
Initiated
August 02, 2017
Classification
Class II
Status
Terminated
Recalling firm
The Harvard Drug Group
Quantity
26,891 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Code information

Item # 263923, all lots

Distribution pattern

Nationwide in the USA

drug · product 4 of 5

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47

D-1122-2017
Recall number
D-1122-2017
Initiated
August 02, 2017
Classification
Class II
Status
Terminated
Recalling firm
The Harvard Drug Group
Quantity
4,715 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Code information

Item # 370339, all lots

Distribution pattern

Nationwide in the USA

drug · product 5 of 5

Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59

D-1123-2017
Recall number
D-1123-2017
Initiated
August 02, 2017
Classification
Class II
Status
Terminated
Recalling firm
The Harvard Drug Group
Quantity
32,413 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Code information

Item# 370281 all lots

Distribution pattern

Nationwide in the USA

Field note

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