Recalls / Class III
Class IIID-0856-2020
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 Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Packaged by GSMS Incorporated, Camarillo, CA 93012
- Affected lot / code info
- 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
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.
Recalling firm
- Firm
- Golden State Medical Supply Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 5187 Camino Ruiz, N/A, Camarillo, California 93012-8601
Distribution
- Quantity
- 379,043 100-ct bottles and 330,997 500-ct bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-02-12
- FDA classified
- 2020-02-26
- Posted by FDA
- 2020-03-04
- Terminated
- 2023-04-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0856-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.