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
Reported: January 28, 2015 Initiated: September 26, 2013 #D-0378-2015
Product Description
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
Reason for Recall
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Details
- Recalling Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Units Affected
- 3,993 cartons
- Distribution
- Nationwide and Puerto Rico.
- Location
- Rockford, IL
Frequently Asked Questions
What product 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. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: 3,993 cartons.
Why was this product recalled? ▼
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 28, 2015. Severity: Moderate. Recall number: D-0378-2015.
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