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Class III: unlikely to cause harmTerminated

Auro Pharmacies Inc. DBA Central Drugs Biotin 10 mg/mL Injection Recall

Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S

Auro Pharmacies Inc. DBA Central Drugs · La Habra, CA

Risk level
Class III
Reported by FDA
Apr 17, 2019
Recall ID
D-1082-2019
Check your lot numberHow we source this data

Summary

Auro Pharmacies Inc. DBA Central Drugs recalled Biotin 10 mg/mL Injection starting Mar 22, 2019. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1082-2019 on Apr 17, 2019. Reason: Failed pH Specification: product does not meet pH label claim. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

Lot 190205@1, expiry 08/4/19

Where it was sold

Nationwide within the United States

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1082-2019
Classification
Class III
Status
Terminated
Recall initiated
Mar 22, 2019
FDA report date
Apr 17, 2019
Quantity
167 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Auro Pharmacies Inc. DBA Central Drugs

Original FDA data

Every field from FDA enforcement report D-1082-2019, exactly as published.

Show all FDA fields
City
La Habra
State
CA
Status
Terminated
Country
United States
Event ID
82483
Address
511 S Harbor Blvd Ste F
Code information
Lot 190205@1, expiry 08/4/19
Postal code
90631-9375
Report date
Apr 17, 2019
Product type
Drugs
Recall number
D-1082-2019
Classification
Class III
Recalling firm
Auro Pharmacies Inc. DBA Central Drugs
Product quantity
167 vials
Termination date
Feb 27, 2020
Reason for recall
Failed pH Specification: product does not meet pH label claim.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Biotin 10 mg/mL Injection, 30 mL vial, Rx only, 511 S. Harbor Blvd., Building. F, La Habra, CA 90631, 562-352-9630.
Distribution pattern
Nationwide within the United States
Recall initiation date
Mar 22, 2019
Initial firm notification
Telephone
Center classification date
Apr 5, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1082-2019, published Apr 17, 2019. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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