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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84816

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

Open FDA event record

Event summary

Timeline bucket
January 28, 2020
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Teva Pharmaceuticals USA

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

Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545

D-0851-2020
Recall number
D-0851-2020
Initiated
January 28, 2020
Classification
Class III
Status
Terminated
Recalling firm
Teva Pharmaceuticals USA
Quantity
2,044,497 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Incorrect

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.

Code information

Lot#: a) 100005876, Exp 02/2020; 100008310, 100008311, Exp 07/2020; 100008638, 100008639, Exp 09/2020; 100011763, 02/2021; b) 100005418, 100005419, 100005420, 100005421, 100005877, 100005878, Exp 01/2020; 100005879, 100005880, 100005881, 100005882, 100005883, 100005884, 100005885, 100005886, 100005887, 100005888, 100005889, 100005890, 100005891, 100005892, 100005893, 100005894, 100005895, 100005896, 100005897, 100005898, 100005899, 100005900, 100005901, 100005902, 100005903, 100006588, 100006718, 100006719, 100006720, 100006721, Exp 02/2020; 100006722,100006724, 100006725, 100006726, 100006727, 100006728, 100006729, 100006730, 100006731, 100006732, 100006733, 100006734, 100006735, 100006736, 100006737, 100006738,100007005, 100007006, 100007007, 100007008, 100007009, 100007010, Exp 03/2020; 100007011, 100007012, 100007013, 100007014, 100007015, 100007016, 100007017, 100007018, 100007019, 100007020, 100007021, 100007022, 100007023, 100007024, 100007025, 100007026, 100007027, 100007028, 100007029, 100007030, 100007031, 100007032, Exp 04/2020; 100007519, 100007520, 100007521, 100007522, 100007523, 100007524, 100007526, 100007527, 100007528, 100007529, 100007530, 100007531, 100007532, 100007533, 100007534, 100007535, 100007536, 100007537, 100007538, 100007539, 100007540, 100007541, Exp 05/2020; 100007849, 100007850, 100007852, 100007853, 100007855, 100007856, 100007858, 100007859, 100007860, 100007861, 100007862, 100007863, Exp 06/2020; 100008296, 100008297, 100008298, 100008299, 100008300, 100008302, 100008303, Exp 07/2020; 100008640, 100008641, 100008643, 100008644, 100008645, 100008646, 100008647, 100008648, 100008649, 100008653, 100008654, 100008655, 100008656, 100008657, 100008658, 100008659, 100008660, 100008661, 100008662, 100008663, 100008664, 100008665, 100008666, 100008667, Exp 08/2020; 100008668, 100008669, 100008670, 100008671, 100009232, 100009233, Exp 09/2020; 100009999, 100010000, 100010001, 100010002, 100010003, 100010004, 100010005, 100010006, 100010007, 100010671, 100010672, 100010673, 100010674, 100010675, 100010676, Exp 12/2020; 100010677, Exp 01/2021; 100010805, 100010806, 100010807, 100010808, 100010809, 100010810, 100010811, 100011709, 100011710, 100011711, 100011712, 100011713, 100011714, 100011715, 100011716, 100011896, Exp 02/2021; 100011897, 100011898, 100011899, 100011900, 100011901, Exp 03/2021; 100011902, 100011903, 100011904, 100011905, 100011906, 100011907, 100011908, 100011909, 100011910, 100011911, 100011912, 100011913, 100011914, 100011918, Exp 04/2021

Distribution pattern

U.S.A. Nationwide

Field note

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