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Class II: temporary or reversible health riskTerminated

American Specialty Pharmacy Hydroxocobalamin Injection Solution 1 mg/mL Recall

Hydroxocobalamin Injection Solution 1 mg/mL Inj

American Specialty Pharmacy · Plano, TX

Risk level
Class II
Reported by FDA
Apr 1, 2015
Recall ID
D-0427-2015
Check your lot numberHow we source this data

Summary

American Specialty Pharmacy recalled Hydroxocobalamin Injection Solution 1 mg/mL starting Dec 12, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0427-2015 on Apr 1, 2015. Reason: Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product. Status: Terminated.

Why it was recalled

Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product

Product description

Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27

Lot numbers, UPCs & expiration codes

Lot# 10082014@10

Where it was sold

TX

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-0427-2015
Classification
Class II
Status
Terminated
Recall initiated
Dec 12, 2014
FDA report date
Apr 1, 2015
Quantity
15 vials
Recall type
Voluntary: Firm initiated
Recalling firm
American Specialty Pharmacy

Original FDA data

Every field from FDA enforcement report D-0427-2015, exactly as published.

Show all FDA fields
City
Plano
State
TX
Status
Terminated
Country
United States
Event ID
70013
Address
2743 W 15th St
Code information
Lot# 10082014@10
Postal code
75075-7525
Report date
Apr 1, 2015
Product type
Drugs
Recall number
D-0427-2015
Classification
Class II
Recalling firm
American Specialty Pharmacy
Product quantity
15 vials
Termination date
Nov 23, 2016
Reason for recall
Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product
Voluntary / mandated
Voluntary: Firm initiated
Product description
Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27
Distribution pattern
TX
Recall initiation date
Dec 12, 2014
Initial firm notification
Telephone
Center classification date
Mar 26, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0427-2015, published Apr 1, 2015. 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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