Drug Enforcement D-66241-001

Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.

Status

Terminated

Classification

Class II

Report Date

October 9, 2013

Termination Date

February 8, 2016

Product Information

Product description
Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
Product quantity
3540 mL
Reason for recall
Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory.
Recall initiation reason
Initial firm notification
Telephone
Distribution pattern
Oklahoma

Location & Firm

Recalling firm
Apothecary Shoppe
Address
6136 E 51st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-66241-001
Event ID
66241
Recall initiation date
September 6, 2013
Center classification date
October 3, 2013
Code info
Lot 05022013@20, Exp 10/29/13
More code info