Urgent: Drug Recall

September 12, 2013

Urgent: Drug Recall

Amlodipine Besylate Tablets, USP 2.5mg, 5mg, 10mg

Recall initiated by the Manufacturer: Mylan Pharmaceuticals Inc. Product Distributed by: Mylan Institutional Inc.

PRODUCT NDC

Name and Strength

Size

51079-450-20 51079-450-63 51079-451-20 51079-451-56 51079-451-19 51079-451-69 51079-452-20 51079-452-56 51079-452-19

Amlodipine Besylate Tablets, USP 2.5 mg Amlodipine Besylate Tablets, USP 2.5 mg Amlodipine Besylate Tablets, USP 5 mg Amlodipine Besylate Tablets, USP 5 mg Amlodipine Besylate Tablets, USP 5 mg Amlodipine Besylate Tablets, USP 5 mg Amlodipine Besylate Tablets, USP 10mg Amlodipine Besylate Tablets, USP 10mg Amlodipine Besylate Tablets, USP 10 mg

UD100 CP30 UD100 PC300 RR25 CP30 UD100 PC300 RR25

REASON

Mylan Institutional Inc. is conducting a voluntary recall of the above referenced products manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, utilizing Active Pharmaceutical Ingredient (API) supplied by Smruthi Organics Ltd., a third party raw material manufacturer. These products are being recalled due to GMP compliance issues identified at Smruthi's manufacturing facility.

ACTION 1. Immediately examine your inventory, quarantine and discontinue distribution of all lots.

2. Carry out a physical count and record this data on the attached form and fax or email as directed on the form.

3. Return the recalled product to:

GENCO Pharmaceutical Services 6101 North 64th Street Milwaukee, WI 53218

ATTN: Amlodipine Recall

OTHER

This Product Recall extends to the retail level. Wholesalers are being requested to contact their customers.

Credit/check will be issued for return of recalled product only.

Any other product returned that is not involved with this product recall will be destroyed and credit will not be issued.

For questions regarding the recall, please call Customer Relations at 1-800-848-0462.

This Product Recall is being conducted with the knowledge of the Food and Drug Administration.

We appreciate your immediate attention and cooperation and sincerely regret any inconvenience caused by this action.

RECALLED LOTS INCLUDE:

51079-450-20 Amlodipine Besylate Tablets, USP 2.5 mg UD100 Lots: 3039792, 3037880, 3043938

51079-450-63 Amlodipine Besylate Tablets, USP 2.5 mg CP30 Lots: 3036811, 3037514, 3039975, 3042583

51079-451-20 Amlodipine Besylate Tablets, USP 5 mg UD100 Lots: 3038339, 3043618

51079-451-56 Amlodipine Besylate Tablets, USP 5 mg PC300 Lots: 3041862, 3044258

51079-451-19 Amlodipine Besylate Tablets, USP 5 mg RR25 Lots: 2120031, 2120067

51079-451-69 Lots:

Amlodipine Besylate Tablets, USP 5 mg CP30 3035787, 3035834, 3035835, 3037125, 3037126, 3037127, 3037511, 3037512, 3037513, 3038113, 3038114, 3038115, 3038116, 3039641, 3039642, 3039643, 3039974, 3040567, 3040977, 3041253, 3041800, 3041801, 3042446, 3042624, 3043015, 3043401, 3043466, 3044590, 3044591, 3045063, 3045064

51079-452-20 Amlodipine Besylate Tablets, USP 10mg UD100 Lots: 3039795, 3042896

51079-452-56 Amlodipine Besylate Tablets, USP 10mg PC300 Lots: 3039793, 3042892

51079-452-19 Amlodipine Besylate Tablets, USP 10 mg RR25 Lots: 2120054, 2120090

September 12 , 2013

AMLODIPINE BESYLATE 2.5 mg, 5 mg and 10 mg TABLETS RECALL TO THE RETAIL LEVEL

Packaged and Distributed by:

Mylan Institutional Inc. (MII), Rockford, IL 61103

COMPANY NAME: ______________________________________________________________

MII ACCOUNT NO (If Applicable): ____________________________________________________

ADDRESS: _______________________________________________________________________

CITY/STATE/ZIP: __________________________________________________________________

TELEPHONE: _____________________________________

CONTACT PERSON: ________________________________ EMAIL: ________________________

DO YOU HAVE STOCK TO RETURN: YES _______ NO _______

IF YES, PLEASE CIRCLE THE LOT(S) AND ENTER THE QUANTITY

51079-450-20 Amlodipine Besylate Tablets, USP 2.5 mg UD100 Lots: 3039792, 3037880, 3043938 Qty to be Returned (Unit Carton): ___________________ (Tablets): _____________

51079-450-63 Amlodipine Besylate Tablets, USP 2.5 mg CP30 Lots: 3036811, 3037514, 3039975, 3042583 Qty to be Returned (Unit Carton): ___________________ (Tablets): _____________

51079-451-20 Amlodipine Besylate Tablets, USP 5 mg UD100 Lots: 3038339, 3043618 Qty to be Returned (Unit Carton): ___________________ (Tablets): _____________

51079-451-56 Amlodipine Besylate Tablets, USP 5 mg PC300 Lots: 3041862, 3044258 Qty to be Returned (Unit Carton): ___________________ (Tablets): _____________

51079-451-19 Amlodipine Besylate Tablets, USP 5 mg RR25 Lots: 2120031, 2120067 Qty to be Returned (Unit Carton): ___________________ (Tablets): _____________

51079-451-69 Amlodipine Besylate Tablets, USP 5 mg CP30 Lots: 3035787, 3035834, 3035835, 3037125, 3037126, 3037127, 3037511, 3037512, 3037513, 3038113, 3038114, 3038115, 3038116, 3039641, 3039642, 3039643, 3039974, 3040567, 3040977, 3041253, 3041800, 3041801, 3042446, 3042624, 3043015, 3043401, 3043466, 3044590, 3044591, 3045063, 3045064 Qty to be Returned (Unit Carton): ___________________ (Tablets): _____________

51079-452-20 Amlodipine Besylate Tablets, USP 10mg UD100 Lots: 3039795, 3042896 Qty to be Returned (Unit Carton): ___________________ (Tablets): _____________

51079-452-56 Amlodipine Besylate Tablets, USP 10mg PC300 Lots: 3039793, 3042892 Qty to be Returned (Unit Carton): ___________________ (Tablets): _____________

51079-452-19 Amlodipine Besylate Tablets, USP 10 mg RR25 Lots: 2120054, 2120090 Qty to be Returned (Unit Carton): ___________________ (Tablets): _____________

PLEASE EMAIL OR FAX THIS COMPLETED FORM TO MII AT THE FOLLOWING:

FAX ? 815.282.9391 EMAIL ? udlemail@

RETURN PRODUCT WITH A COPY OF THIS FORM DIRECTLY TO:

GENCO Pharmaceutical Services ATTN: MYLAN INSTITUTIONAL INC. AMLODIPINE BESYLATE RECALL 6101 North 64th Street Milwaukee, WI 53218

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download