Multi-event April 2015 FDA Recall Drug by South Coast Specialty Compounding, Inc.
This Multi-event Class II drug recall was voluntarily initiated by South Coast Specialty Compounding, Inc. on April 23, 2015 for the product Drug. The FDA reported the reason for recall as penicillin cross contamination. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
D-1415-2015 D-1340-2015 D-1408-2015 D-1337-2015 D-1411-2015 D-1410-2015 D-1338-2015 D-1407-2015 D-1339-2015 D-1414-2015 D-1412-2015 D-1342-2015 D-1409-2015 D-1341-2015 D-1413-2015
Recall Number: D-1415-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
24 suppositories (24 prescriptions)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration 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
Recall Number: D-1340-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
172 vials ( 100 prescriptions)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
Lot# 12032014@2B; Exp.06/15
Lot# 12072014@3B; Exp.06/15
Lot# 01032015@2B; Exp.07/15
Lot# 02152015@2B; Exp.08/15
Recall Number: D-1408-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
2,370 capsules (40 prescriptions)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
Lot# All Lots, Exp 09/15
Recall Number: D-1337-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
ALL LOTS
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
Lot# All Lots, Exp 09/15
Recall Number: D-1411-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
61 prescriptions
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
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
Recall Number: D-1410-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
5 prescriptions
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
Lot# 01152015@20,03032015@22, 03032015@22, 03092015@55,12052014@20; Exp 07/15
Recall Number: D-1338-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
2,355 capsules ( 26 presciptions)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
Lot# All Lots; Exp 06/15
Recall Number: D-1407-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
2,380 capsules ( 39 prescriptions)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
Lot# All Lots, Exp 09/15
Recall Number: D-1339-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
40 capsules ( 1 prescription)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation
Batch or Lot Expiration Information
Lot# All lots; Exp 08/15
Recall Number: D-1414-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
36 prescriptions
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration 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
Recall Number: D-1412-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
211 presciptions
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
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
Recall Number: D-1342-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
335 vials (114 prescriptions)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
Batch or Lot Expiration Information
Lot# 11152014@1B, Exp 05/15
Lot# 02082015@3B, Exp 08/14
Recall Number: D-1409-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
540 capsules (11 prescriptions)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
Lot# All Lots; Exp 09/15
Recall Number: D-1341-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
337 vials (112 prescriptions)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
Batch or Lot Expiration Information
Lot# 120322014@1B, Exp 05/15
Recall Number: D-1413-2015
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
04-23-2015
09-09-2015
24 prescriptions
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
South Coast Specialty Compounding, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
05-31-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Batch or Lot Expiration Information
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
