Tramadol Hydrochloride Tablets recall: Labeling Error
TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva…
Why was Tramadol Hydrochloride Tablets 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 Numbers: a) GS021259, Exp. Date 11/31/2019; GS021742, GS022074, Exp. 2/29/2020; GS022619, GS022836, 3/31/2020; GS023243, GS023631, Exp. 4/30/2020; GS023869, GS024562, GS025492, Exp. 5/31/2020; GS025184, Exp. 6/30/2020; GS026306, Exp. 9/30/2020; GS026654, Exp.=12/31/2020; GS027566, Exp. 2/28/2020; GS028574, Exp. 4/30/2021; b) GS021570, GS021444, GS021445, GS021443, GS021447, GS021446, 11/31/2019; GS021745, GS021746, GS021744, GS022076, GS022077, GS022078, GS022075, GS021747, GS021748, Exp. 2/29/2020; GS022622, GS022623, GS022624, GS022620, GS022837, GS022838, GS022856, GS022621, Exp. 3/31/2020; GS023029, GS023028, GS023027, Exp. 4/30/2020; GS023958, GS023959, GS023960, GS025045, GS024929, GS025048,GS025047, GS025588, GS025046, Exp. Date 5/31/2020; GS025260, GS025259, Exp.6/30/2020; GS025717, GS025719, GS025718, Exp. 8/31/2020; GS023607, GS026308, GS026309, Exp. 9/30/2020; GS026912, GS026911, GS026910, Exp. 12/31/2020; GS027678, Exp. 2/28/2021; GS027836, Exp. 11/30/2020; GS027570, GS027569, Exp. 2/28/2020; GS027572, GS027571, Exp. 4/30/2021
- Product
- TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC 60429-588-05) Manufactured by Teva…
- Recalling firm
- Golden State Medical Supply Inc.
- Quantity
- 379,043 100-ct bottles and 330,997 500-ct bottles
- Distribution
- Distributed Nationwide in the USA
- Recall date
- March 4, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)