Class III · Low risk
Lamivudine Tablets
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Triumeq (abacavir, dolutegravir, and lamivudine)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Park, NC 27709
Affected NDC
49702-0231-13
Compare with the code on your package — it is the most precise check available.
Drug: Lamivudine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Triumeq abacavir sulfate, dolutegravir sodium, lamivudine NDC 49702-0231 |
ABACAVIR SULFATE 600 mg/1; DOLUTEGRAVIR SODIUM 50 mg/1; LAMIVUDINE 300 mg/1 | Tablet, Film Coated Oral |
ViiV Healthcare Company | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 49702-231-13
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0486-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Lamivudine recalls
See all
Class III · Low risk
Lamivudine Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Class II · Moderate risk
Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters
Failed dissolution specifications
Class II · Moderate risk
Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg)
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.