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Recall Observatory FDA recall evidence

Drug product

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

D-1415-2015

April 23, 2015

Class II

Product summary

Firm
South Coast Specialty Compounding, Inc.
Event
Event 71078
Status
Terminated
Classification
Class II
Quantity
24 suppositories (24 prescriptions)
Official record key
drug-enforcement:D-1415-2015

Official wording

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

Code information: Lot #: 01052015@12 01132015@2 01132015@36 01132015@37 01152015@4 01162015@66 01202015@34 02112015@11 02112015@11 02252015@34 10312014@13 11042014@42 11052014@46 11072014@21 11122014@43 11122014@45 11182014@15 11192014@41 11242014@29 11262014@14 12022014@13 12102014@4 12192014@40 12222014@18 Exp. 07/15

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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