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Class II: temporary or reversible health riskTerminated

Bedford Pharmacy Testosterone Cypionate Recall

Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 R…

Bedford Pharmacy · Bedford, NH

Risk level
Class II
Reported by FDA
Oct 21, 2015
Recall ID
D-0046-2016
Check your lot numberHow we source this data

Summary

Bedford Pharmacy recalled Testosterone Cypionate starting Sep 22, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0046-2016 on Oct 21, 2015. Reason: Lack of assurance of sterility. Status: Terminated.

Why it was recalled

Lack of assurance of sterility

Product description

Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Lot numbers, UPCs & expiration codes

Lot #: 09082015@12, Exp10/23/2015; 09032015@16, Exp 10/18/2015

Where it was sold

NH, MA

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-0046-2016
Classification
Class II
Status
Terminated
Recall initiated
Sep 22, 2015
FDA report date
Oct 21, 2015
Quantity
3 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Bedford Pharmacy

Original FDA data

Every field from FDA enforcement report D-0046-2016, exactly as published.

Show all FDA fields
City
Bedford
State
NH
Status
Terminated
Country
United States
Event ID
72233
Address
209 Route 101
Code information
Lot #: 09082015@12, Exp10/23/2015; 09032015@16, Exp 10/18/2015
Postal code
03110-5440
Report date
Oct 21, 2015
Product type
Drugs
Recall number
D-0046-2016
Classification
Class II
Recalling firm
Bedford Pharmacy
Product quantity
3 vials
Termination date
Jun 8, 2016
Reason for recall
Lack of assurance of sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Distribution pattern
NH, MA
Recall initiation date
Sep 22, 2015
Initial firm notification
Letter
Center classification date
Oct 15, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0046-2016, published Oct 21, 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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