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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72956

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

Open FDA event record

Event summary

Timeline bucket
April 29, 2015
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

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

Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04.

D-0560-2016
Recall number
D-0560-2016
Initiated
April 29, 2015
Classification
Class II
Status
Terminated
Quantity
45,022 bottles

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: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

Code information

Lot #s: a) J12A48, Exp 10/14, L12A23, Exp 12/14, A13G04, A13H14, Exp 01/15, B13E97, Exp 02/15, C13B55, Exp 03/15, J13F75, L13C93, A14F78, A14H17, B14A6, Exp 08/15, I13D47, I13G28, Exp 09/15, J13D73, J13D93 Exp 10/15, K13E18, 11/15, A14H06, C14A49, C14D01, Exp 12/15, A14B95 01/16.

Distribution pattern

Nationwide

drug · product 2 of 2

Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.

D-0561-2016
Recall number
D-0561-2016
Initiated
April 29, 2015
Classification
Class II
Status
Terminated
Quantity
17,533 bottles

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: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

Code information

Lot #s: J12C03, J12D19, Exp 10/14, L12B52, L12E79, L12G92, Exp 12/14, A13G14, A13H49, Exp 01/15, B13G53, Exp 02/15, D13A66, Exp 04/15, E13E35, Exp 05/15, F13A58, F13D85, F13F17, F13F27, Exp 06/15, G13D37, G13E57, Exp 07/15, H13A65, H13A74, H13C13, H13G01, Exp 08/15, I13C02, I13G98, Exp 09/15, J13C53, J13G90, Exp 10/15, K13A65, K13B73, K13C98, K13E61, Exp 11/15, L13C59, L13F49, A14C27, A14D09, A14F11, Exp 12/15.

Distribution pattern

Nationwide