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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

South Coast Specialty Compounding, Inc.: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Agency Publication Date: September 2, 2015
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Affected Products

Product: Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA

All Lots, Exp 09/15

Product: Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA

All Lots; Exp 06/15

Product: Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation

All lots; Exp 08/15

Product: Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA

Lot # 12032014@2B; Exp.06/15 Lot # 12072014@3B; Exp.06/15 Lot # 01032015@2B; Exp.07/15 Lot # 02152015@2B; Exp.08/15

Lot Numbers:
12032014
12072014
01032015
02152015
Product: Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA

Lot # 120322014@1B, Exp 05/15

Lot Numbers:
120322014
Product: Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA

Lot # 11152014@1B, Exp 05/15 Lot # 02082015@3B, Exp 08/14

Lot Numbers:
11152014
02082015
Product: Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA

All Lots, Exp 09/15

Product: Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA

All Lots, Exp 09/15

Product: Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA

All Lots; Exp 09/15

Product: Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA

Lot # 01152015@20,03032015@22, 03032015@22, 03092015@55,12052014@20; Exp 07/15

Lot Numbers:
01152015
Product: Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA

Lot #: 01022015@46 01022015@50 01052015@23 01072015@38 01072015@39 01082015@36 01082015@9 01092015@26 01122015@40 01142015@11 01142015@16 01152015@44 01162015@31 01162015@38 01192015@35 01222015@17 01222015@19 01272015@38 02022015@30 02022015@30 02062015@35 02112015@30 02112015@30 02202015@3 02202015@3 10272014@39 10312014@14 10312014@36 11042014@29 11042014@39 11042014@52 11072014@38 11072014@38 11072014@38 11072014@38 11072014@7 11112014@4 11132014@29 11142014@17 11182014@45 11192014@31 11202014@49 11242014@44 11252014@59 11252014@59 11252014@59 11252014@59 11252014@59 11252014@59 11282014@14 12012014@21 12012014@22 12022014@20 12022014@38 12092014@5 12092014@56 12092014@66 12112014@22 12152014@28 12152014@44 12152014@56 12162014@30 12172014@23 12172014@36 12222014@6 12232014@57 12242014@15 12262014@11 12262014@11 12262014@24 12312014@23 Exp. 07/15

Lot Numbers:
01022015
Product: Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA

Lot #: 01022015@18 01022015@26 01052015@34 01052015@39 01052015@57 01062015@52 01082015@29 01082015@57 01082015@60 01092015@23 01092015@26 01092015@27 01092015@28 01092015@29 01092015@31 01092015@43 01092015@44 01092015@45 01122015@42 01122015@63 01132015@35 01132015@36 01132015@37 01132015@44 01132015@52 01142015@50 01152015@20 01152015@31 01162015@14 01162015@5 01162015@60 01162015@8 01192015@28 01192015@32 01192015@53 01202015@19 01202015@29 01202015@33 01202015@34 01202015@36 01212015@38 01232015@13 01232015@19 01232015@30 01232015@48 01262015@26 01262015@32 01262015@34 01262015@36 01262015@42 01272015@2 01272015@33 01272015@4 01282015@5 02032015@41 02032015@41 02032015@41 02162015@62 02162015@62 02182015@47 02242015@26 03032015@22 03032015@22 03032015@22 03042015@41 03062015@31 03062015@61 03092015@55 10272014@19 10272014@29 10272014@43 10282014@11 10282014@49 10292014@15 10292014@31 10292014@32 10312014@13 10312014@27 11032014@34 11032014@38 11032014@64 11032014@75 11042014@27 11042014@32 11052014@25 11052014@4 11052014@43 11052014@44 11052014@46 11052014@50 11062014@3 11072014@15 11072014@20 11072014@35 11102014@34 11102014@52 11112014@1 11112014@51 11122014@1 11122014@3 11122014@37 11122014@44 11122014@45 11122014@53 11122014@55 11132014@58 11142014@35 11142014@36 11172014@10 11172014@33 11182014@15 11182014@3 11182014@6 11192014@8 11202014@36 11202014@43 11202014@50 11202014@53 11202014@9 11212014@17 11212014@27 11242014@26 11242014@28 11242014@58 11252014@26 11252014@33 11252014@37 11252014@4 11252014@50 11262014@61 11282014@2 11282014@31 11282014@35 12012014@20 12012014@22 12022014@9 12032014@19 12032014@39 12042014@3 12052014@23 12052014@31 12052014@33 12052014@9 12082014@22 12082014@31 12082014@46 12092014@72 12102014@2 12102014@4 12102014@56 12112014@47 12112014@50 12122014@6 12152014@23 12152014@29 12152014@45 12152014@46 12152014@53 12152014@67 12162014@24 12162014@29 12162014@4 12162014@44 12172014@10 12172014@30 12172014@37 12182014@14 12182014@2 12182014@5 12192014@11 12192014@17 12192014@29 12222014@36 12222014@47 12232014@26 12232014@29 12232014@31 12232014@32 12232014@41 12232014@48 12232014@5 12232014@51 12232014@56 12242014@18 12242014@26 12262014@19 12262014@4 12292014@26 12292014@56 12302014@21 12302014@46 12312014@14 12312014@2 12312014@20 Exp. 07/15

Lot Numbers:
01022015
Product: Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA

Lot # 01022015@21 01022015@41 01052015@61 01122015@36 01162015@62 01162015@64 01202015@51 01212015@28 10272014@18 11032014@50 11132014@26 11142014@25 11242014@46 11242014@9 12032014@20 12052014@18 12122014@21 12152014@35 12152014@57 12162014@32 12172014@12 12182014@6 12222014@51 12302014@22 Exp. 07/15

Lot Numbers:
01022015
Product: Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA

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

Lot Numbers:
01022015
Product: Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA

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

Lot Numbers:
01052015

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 71078
Status: Resolved
Manufacturer: South Coast Specialty Compounding, Inc.
Manufactured In: United States
Units Affected: 15 products (ALL LOTS; 2,355 capsules ( 26 presciptions); 40 capsules ( 1 prescription); 172 vials ( 100 prescriptions); 337 vials (112 prescriptions); 335 vials (114 prescriptions); 2,380 capsules ( 39 prescriptions); 2,370 capsules (40 prescriptions); 540 capsules (11 prescriptions); 5 prescriptions; 61 prescriptions; 211 presciptions; 24 prescriptions; 36 prescriptions; 24 suppositories (24 prescriptions))

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.