Drug Enforcement D-966-2013

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Status

Terminated

Classification

Class II

Report Date

September 18, 2013

Termination Date

July 18, 2014

Product Information

Product description
H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
Product quantity
N/A
Reason for recall
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
USA nationwide

Location & Firm

Recalling firm
Beacon Hill Medical Pharmacy, P.C.
Address
18161 W 13 Mile Rd, Suite A1

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-966-2013
Event ID
65876
Recall initiation date
July 26, 2013
Center classification date
September 10, 2013
Code info
01242013@23, 03132013@20, 04232013@21, 06112013@31, 03282013@24, 02042013@9, 03092013@6, 04122013@10, 04232013@24, 05232013@8, 06192013@26, 07102013@18, 07132013@6, 01072013@3, 02192013@10, 04172013@23, 06192013@28, 07102013@15, 07132013@8, 03232013@4, 03282013@22, 01032013@5, 01182013@24, 02052013@8, 03062013@5, 04122013@4, 04232013@26, 05132013@15, 05232013@5, 06182013@31, 06212013@12, 07132013@4, 03282013@27, 01032013@3, 01242013@16, 02192013@7, 03062013@2, 04122013@8, 04232013@29, 05232013@10, 06112013@28, 06182013@36, and 06242013@21.
More code info
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