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Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 ...

FDA Recall #D-0342-2019 — Class III — December 10, 2018

Recall #D-0342-2019 Date: December 10, 2018 Classification: Class III Status: Terminated

Product Description

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

Reason for Recall

Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

Recalling Firm

CBI Laboratories, Inc. — Fort Worth, TX

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

2055 tubes

Distribution

United States, Maldives, Canada, United Arab Emirates, and New Zealand

Code Information

Lot #: 129114 Exp. 06/2019; 131927,133239 Exp. 03/2020; 126292, Exp.01/2019.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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