Fentanyl injectable 2000 mcg/mL packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247...

FDA Drug Recall #D-0080-2015 — Class II — August 27, 2014

Recall Summary

Recall Number D-0080-2015
Classification Class II — Moderate risk
Date Initiated August 27, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Martin Avenue Pharmacy, Inc.
Location Naperville, IL
Product Type Drugs
Quantity 40 mL

Product Description

Fentanyl injectable 2000 mcg/mL packaged in 30 mL or 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Reason for Recall

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Distribution Pattern

Nationwide

Lot / Code Information

Lot Number: 07292014@37, Exp 10/27/2014

Other Recalls from Martin Avenue Pharmacy, Inc.

Recall # Classification Product Date
D-0118-2015 Class II Phentolamine mesylate 5 mg/35 mg/mannitol tritu... Aug 27, 2014
D-0130-2015 Class II Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverin... Aug 27, 2014
D-0086-2015 Class II Hyaluronidase injection solution (PF) 150 U/mL ... Aug 27, 2014
D-0063-2015 Class II Benzalkonium chloride water for injection packa... Aug 27, 2014
D-0094-2015 Class II Hydroxyzine hydrochloride 25 mg/mL injectable p... Aug 27, 2014

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.