Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68671

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

Open FDA event record

Event summary

Timeline bucket
June 26, 2014
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Poly Pharmaceuticals, 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

POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-713-16.

D-1431-2014
Recall number
D-1431-2014
Initiated
June 26, 2014
Classification
Class III
Status
Terminated
Recalling firm
Poly Pharmaceuticals, Inc
Quantity
208 Bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

Code information

Lot #: 04413, Expiry: 02/15

Distribution pattern

U.S. Nationwide

drug · product 2 of 2

LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC: 50991-515-16.

D-1432-2014
Recall number
D-1432-2014
Initiated
June 26, 2014
Classification
Class III
Status
Terminated
Recalling firm
Poly Pharmaceuticals, Inc
Quantity
102 Bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".

Code information

Lot #: 03613, Expiry: 02/15

Distribution pattern

U.S. Nationwide