Teva Recalls Tramadol Tablets Due to Incorrect Package Insert Labeling
Teva Pharmaceuticals 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error.
Plain-English summary
Teva Pharmaceuticals USA is recalling specific lots of Tramadol Hydrochloride Tablets USP CIV, 50 mg. The affected products are packaged in 100-count and 500-count bottles and are prescription-only. The recall covers 2,044,497 bottles distributed nationwide in the United States.
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. This instruction is incorrect for the unscored tablets being recalled.
Consumers who have these specific lots of Tramadol Hydrochloride 50 mg tablets should contact their healthcare provider or pharmacist for guidance. The recall is classified as Class III by the FDA, indicating that the violation is not likely to cause adverse health consequences.
The recalled product
- Product
- Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,044,497
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#: a) 100005876
- Exp 02/2020
- 100008310
- 100008311
- Exp 07/2020
- 100008638
- 100008639
- Exp 09/2020
- 100011763
- 02/2021
- b) 100005418
- 100005419
- 100005420
- 100005421
- 100005877
- 100005878
- Exp 01/2020
- 100005879
- 100005880
- 100005881
Distribution
Distributed nationwide across the United States.
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