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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Golden State Medical Supply Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0856-2020
Related Recalls
Failed Dissolution Specifications
PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30
Golden State Medical Supply
Failed Dissolution Specifications
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.