FDAClass IISeptember 9, 2015

Bi-Est recall: Contamination

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

Why was Bi-Est recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA
Recalling firm
South Coast Specialty Compounding, Inc.
Quantity
24 suppositories (24 prescriptions)
Distribution
Nationwide.
Recall date
September 9, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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