Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, ...

FDA Drug Recall #D-0047-2016 — Class II — September 22, 2015

Recall Summary

Recall Number D-0047-2016
Classification Class II — Moderate risk
Date Initiated September 22, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bedford Pharmacy
Location Bedford, NH
Product Type Drugs
Quantity 2 vial

Product Description

Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919

Reason for Recall

Lack of assurance of sterility

Distribution Pattern

NH, MA

Lot / Code Information

Lot #: 09032015@16 , Exp 10/18/2015

Other Recalls from Bedford Pharmacy

Recall # Classification Product Date
D-0051-2016 Class II P-P (COBAL)30-0.5/mL, Injection, Bedford Pharma... Sep 22, 2015
D-0040-2016 Class II Methylcobalamin (preservative Free) 1 mg/mL Inj... Sep 22, 2015
D-0050-2016 Class II P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford ... Sep 22, 2015
D-0041-2016 Class II P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Ph... Sep 22, 2015
D-0044-2016 Class II Hydroxocobalamin 20 mg/mL Injection, Bedford Ph... Sep 22, 2015

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.