D-1414-2015 Class II Terminated

Recalled by South Coast Specialty Compounding, Inc. — Irvine, CA

Recall Details

Product Type
Drugs
Report Date
September 9, 2015
Initiation Date
April 23, 2015
Termination Date
May 31, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36 prescriptions

Product Description

Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA

Reason for Recall

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Distribution Pattern

Nationwide.

Code Information

Lot #: 01022015@18 01132015@36 01132015@44 01142015@39 01152015@20 01222015@36 01232015@30 01272015@2 01282015@5 03102015@21 03122015@50 03122015@50 10312014@27 11052014@4 11062014@3 11072014@20 11102014@1 11112014@35 11122014@15 11122014@45 11132014@58 11142014@35 11252014@50 11282014@2 12032014@39 12082014@31 12102014@4 12152014@32 12162014@4 12172014@10 12192014@17 12192014@29 12232014@56 12242014@26 12262014@19 12312014@2 Exp. 07/15