Golden State Medical Supply Recalls Tramadol Tablets Due to Labeling Error
Golden State Medical Supply is recalling Tramadol Hydrochloride 50 mg tablets because the patient leaflets contain incorrect dosing instructions for unscored tablets.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The issue is a minor labeling error regarding dosing instructions for unscored tablets, fitting the criteria for a Low severity score.
Plain-English summary
Golden State Medical Supply Inc. is recalling specific lots of Tramadol Hydrochloride Tablets, USP, 50 mg, Rx Only. The affected products are 100-count and 500-count bottles manufactured by Teva Czech Industries, s.r.o. and packaged by GSMS Incorporated. The recall covers 379,043 100-count bottles and 330,997 500-count bottles distributed nationwide in the USA.
The recall was initiated due to a labeling error. The patient leaflets included with the specified lots of unscored tablets contain language regarding a 25 mg dosing titration that requires the use of a scored 50 mg tablet. Since the recalled tablets are unscored, the instructions are incorrect for this specific product form.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be returned to the supplier or disposed of according to local regulations. No adverse health consequences are expected from this labeling error.
The recalled product
- 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
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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