Exact FDA event identifier

Event 82483

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 22, 2019
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Auro Pharmacies Inc. DBA Central Drugs

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.

D-1082-2019

Recall number: D-1082-2019
Initiated: March 22, 2019
Classification: Class III
Status: Terminated
Recalling firm: Auro Pharmacies Inc. DBA Central Drugs
Quantity: 167 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Failed pH Specification: product does not meet pH label claim.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed pH Specification: product does not meet pH label claim.

Code information

Lot 190205@1, expiry 08/4/19

Distribution pattern

Nationwide within the United States