Mylan Institutional, Inc. (d.b.a. UDL Laboratories): CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Agency Publication Date: January 21, 2015

Affected Products

Product: CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.

Lot Number: 3034630; Expiration Date: 12/13; NDC: 51079-182-20

Lot Numbers:

Number

Product: 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

Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66607

Status: Resolved

Manufacturer: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Manufactured In: United States

Units Affected: 2 products (11,650 cartons; 3,993 cartons)

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Sources: FDA iRES · Raw API Response

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Affected Products

Product: CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.

Lot Number: 3034630; Expiration Date: 12/13; NDC: 51079-182-20

Lot Numbers:

Number

Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;

Lot Numbers:

Number