B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobala...

FDA Drug Recall #D-1398-2014 — Class II — May 12, 2014

Recall Summary

Recall Number D-1398-2014
Classification Class II — Moderate risk
Date Initiated May 12, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm John W Hollis Inc
Location Nashville, TN
Product Type Drugs
Quantity 30 mL

Product Description

B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chloride 0.01g, Cyanocobalamin 0.3mg, Inositol 0.05g, Methionine 0.015g, Levocarnitine 0.1g, Chromic Chloride 0.15g, Lidocaine HCl 0.01g, Pyrodoxine HCl 0.005g, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234

Reason for Recall

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Distribution Pattern

Nationwide

Lot / Code Information

Lot # 2095, Use by 8/17/14

Other Recalls from John W Hollis Inc

Recall # Classification Product Date
D-1406-2014 Class II Polidocanol 1% Solution for Injection, each mL ... May 12, 2014
D-1388-2014 Class II Polidocanol 0.5% Solution for Injection, Polid... May 12, 2014
D-1394-2014 Class II Mannitol 5% Solution for injection, Mannitol 50... May 12, 2014
D-1399-2014 Class II Papaverine HCl 30 mg, Phentolamine Mesylate 2 m... May 12, 2014
D-1390-2014 Class II CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOU... May 12, 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.