Class II · Moderate risk
Triumeq (abacavir, dolutegravir, and lamivudine)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lamivudine Oral Solution
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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).
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70
Affected NDC
54838-0566-70
Compare with the code on your package — it is the most precise check available.
Drug: Lamivudine
- Recalling firm
- Silarx Pharmaceutical, Inc.
- NDC code
- 54838-0566-70
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1416-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 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.
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 labeling / mix-up recalls from 2015
All labeling / mix-up recalls
Class III · Low risk
Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Class III · Low risk
Lumizyme (alglucosidase alpha)
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
NABUMETONE Tablets USP
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Class II · Moderate risk
Rocuronium Bromide 50 MG/5ML INJ.
Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
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.