Multi-event April 2015 FDA Recall Drug by Mission Pharmacal Co
This Multi-event Class II drug recall was voluntarily initiated by Mission Pharmacal Co on April 30, 2015 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1064-2015
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
04-30-2015
05-20-2015
2,412 Kits
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.
Mission Pharmacal Co
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 and Puerto Rico
01-26-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23
Batch or Lot Expiration Information
Lot# : 119814, Exp 05/31/2016
Recall Number: D-1065-2015
Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.
04-30-2015
05-20-2015
1,992 Kits
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.
Mission Pharmacal Co
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 and Puerto Rico
01-26-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23
Batch or Lot Expiration Information
Lot# : 526014, Exp. 05/31/2016
