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
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