Class III · Low risk
Lamotrigine Tablets
Labeling: Label Error on Declared Strength
Lamotrigine Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
Affected NDC
51079-0866-20
Compare with the code on your package — it is the most precise check available.
Drug: Lamotrigine
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- NDC code
- 51079-866-20
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0378-2015 · 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 Lamotrigine recalls
See all
Class II · Moderate risk
Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class III · Low risk
Lamotrigine Tablets
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
Class I · High risk
Lamotrigine Tablets
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Other recalls by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
All 2013 recalls
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Super-Potent Drug: Out of specification potency results were obtained.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent and Superpotent Drug
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