Multi-event December 2018 FDA Recall Drug by Cbi Laboratories, Inc.
This Multi-event Class III drug recall was voluntarily initiated by Cbi Laboratories, Inc. on December 10, 2018 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in United States, Maldives, Canada, United Arab Emirates, and New Zealand and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0342-2019
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
12-10-2018
12-26-2018
2055 tubes
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
CBI Laboratories, 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.
United States, Maldives, Canada, United Arab Emirates, and New Zealand
01-14-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155
Batch or Lot Expiration Information
Lot# : 129114 Exp. 06/2019; 131927,133239 Exp. 03/2020; 126292, Exp.01/2019.
Recall Number: D-0341-2019
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
12-10-2018
12-26-2018
5363 tubes
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
CBI Laboratories, 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.
United States, Maldives, Canada, United Arab Emirates, and New Zealand
01-14-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Batch or Lot Expiration Information
Lot# : 131965, Exp 12/2018; 127426 Exp. 01/2019; 129045, 130424 Exp. 06/2019; 130432 Exp. 10/2019; 131870 Exp. 06/2019; 132648, Exp. 03/2020; 133732 Exp. 04/2020; 134400 Exp. 02/2020; 135345 Exp. 08/2020
