Tramadol Hydrochloride Tablets USP CIV recall: Labeling Error
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
Why was Tramadol Hydrochloride Tablets USP CIV recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 2,044,497 bottles
- Distribution
- U.S.A. Nationwide
- Recall date
- February 26, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)