Unrated Drug recall · FDA · Published March 22, 2019

Central Drugs Biotin Injection Recall: Failed pH Specification

Central Drugs recalls Biotin 10 mg/mL injection vials due to failed pH specification. This may affect product safety and labeling accuracy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1082-2019Drug Central Drugs ›

Recall notice

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

Take action

Contact the company

Recalling firmAuro Pharmacies Inc. DBA Central Drugs511 S Harbor Blvd Ste F · La Habra, CA 90631-9375

✎ GovInfoNow plain-language explainer

Central Drugs is recalling Biotin 10 mg/mL injection vials that do not meet pH label claims. This could impact product safety and labeling accuracy for medical use. Read more at govinfonow.com/recall/39076-central-drugs-biotin-injection-recall-failed-ph-specification.

Source Summary by GovInfoNow · govinfonow.com/recall/39076-central-drugs-biotin-injection-recall-failed-ph-specification · Updated October 5, 2026 · FDA enforcement record: FDA #D-1082-2019

Cite this page

“Central Drugs Biotin Injection Recall: Failed pH Specification.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39076-central-drugs-biotin-injection-recall-failed-ph-specification. Based on FDA recall #D-1082-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1082-2019%22&limit=1).

The FDA announced on March 22, 2019, that Auro Pharmacies Inc. DBA Central Drugs is recalling Biotin 10 mg/mL Injection due to a failed pH specification. The Class III recall involves 167 vials distributed nationwide.

How to tell if you have it

Brand: Central Drugs
Product: Biotin 10 mg/mL Injection, 30 mL vial
Lot code: 190205@1
Expiry date: 08/4/19

The hazard

The product does not meet the pH label claim, according to the FDA. The agency classified this as a Class III recall.

Context

GovInfoNow's records show other recent recalls of similar products include Somerset Therapeutics Cisatracurium Besylate Injection Recall (2025-11-26), American Regent Levocarnitine Injection Recall (2026-04-16), and Baxter Vasopressin Injection Recall (2026-08-06).

How to tell if you have this one

Check for the Biotin 10 mg/mL Injection, 30 mL vial, Rx only, manufactured by Central Drugs. Lot 190205@1 with expiry 08/4/19.

Brand
Central Drugs
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the product name, lot number, and expiration date to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

Mar 22, 2019Firm started the recall
Apr 5, 2019FDA classified it Class III
Apr 17, 2019Published in FDA’s Enforcement Report
Feb 27, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/39076-central-drugs-biotin-injection-recall-failed-ph-specification">Central Drugs Biotin Injection Recall: Failed pH Specification (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1082-2019 (March 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1082-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.