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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81775

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 10, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
CBI Laboratories, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.

D-0341-2019
Recall number
D-0341-2019
Initiated
December 10, 2018
Classification
Class III
Status
Terminated
Recalling firm
CBI Laboratories, Inc.
Quantity
5363 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code 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

Distribution pattern

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

drug · product 2 of 2

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

D-0342-2019
Recall number
D-0342-2019
Initiated
December 10, 2018
Classification
Class III
Status
Terminated
Recalling firm
CBI Laboratories, Inc.
Quantity
2055 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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