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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80791

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 07, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
PD-Rx 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

1 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 1

Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged By PD-Rx Pharmaceuticals, Oklahoma City, OK 73127.

D-1127-2018
Recall number
D-1127-2018
Initiated
August 07, 2018
Classification
Class II
Status
Terminated
Quantity
6,641 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.

Code information

Lot #: a) D17D29, L17C73, F18E73, Exp. 1/31/19; b) H17D70, K17F66, G18F26, Exp. 1/31/19; c) C18G26, F18E36, Exp. 1/31/19; d) F18A85, Exp. 1/31/19; e) K17B44, K17E29, L17D93, Exp. 1/31/19; E17B88, Exp. 5/31/19; H17A52, H17D67, Exp. 7/31/19; f) E17B01, E17E83, Exp. 5/31/19; F17C99, Exp. 6/30/19; G17C08, G17E18, H17B01, H17B66, H17F67, I17A56, Exp. 7/31/19; g) E17E27, Exp. 1/31/19, I17A33, G17D62, Exp. 7/31/19; h) E17B35, E17D90, Exp. 5/31/19, F17C13, Exp. 6/30/19, G17B25, H17C58, Exp. 7/31/19; i) G17D59, Exp. 7/31/19; j) I17A69, G17D58, Exp. 7/31/19; k) G17D56, Exp. 7/31/19.

Distribution pattern

Nationwide in the USA.