Reported Mar 4, 2020 · Terminated
TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC 60429-588-01) b) 500-count bottle (NDC…
Golden State Medical Supply Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Golden State Medical Supply Inc. · 5187 Camino Ruiz · Camarillo, CA · 93012-8601
Is this the product you have?
- 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 Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
- Lot codes and dates
23 of 23 products
Products covered by this recall # Product as published 1 GS021259, Exp. Date 11/31/2019 2 GS021742, GS022074, Exp. 2/29/2020 3 GS022619, GS022836, 3/31/2020 4 GS023243, GS023631, Exp. 4/30/2020 5 GS023869, GS024562, GS025492, Exp. 5/31/2020 6 GS025184, Exp. 6/30/2020 7 GS026306, Exp. 9/30/2020 8 GS026654, Exp.=12/31/2020 9 GS027566, Exp. 2/28/2020 10 GS028574, Exp. 4/30/2021 11 GS021570, GS021444, GS021445, GS021443, GS021447, GS021446, 11/31/2019 12 GS021745, GS021746, GS021744, GS022076, GS022077, GS022078, GS022075, GS021747, GS021748, Exp. 2/29/2020 13 GS022622, GS022623, GS022624, GS022620, GS022837, GS022838, GS022856, GS022621, Exp. 3/31/2020 14 GS023029, GS023028, GS023027, Exp. 4/30/2020 15 GS023958, GS023959, GS023960, GS025045, GS024929, GS025048,GS025047, GS025588, GS025046, Exp. Date 5/31/2020 16 GS025260, GS025259, Exp.6/30/2020 17 GS025717, GS025719, GS025718, Exp. 8/31/2020 18 GS023607, GS026308, GS026309, Exp. 9/30/2020 19 GS026912, GS026911, GS026910, Exp. 12/31/2020 20 GS027678, Exp. 2/28/2021 - Amount recalled
- 379,043 100-ct bottles and 330,997 500-ct bottles
Where it was sold
- Nationwide
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Golden State Medical Supply Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.