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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Premier Pharmacy Labs Inc: Various Injectable and Ophthalmic Medications Recalled for Sterility Risks

Agency Publication Date: June 21, 2019
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Summary

Premier Pharmacy Labs Inc is recalling 40,220 units of various injectable and ophthalmic drugs, including Sodium Bicarbonate, Succinylcholine Chloride, and Neostigmine Methylsulfate, because they may not be sterile. An FDA inspection revealed that the manufacturing facility had insufficient environmental controls and potential cross-contamination issues, which means the medications could be contaminated with bacteria or other pathogens. These products were distributed nationwide in the USA to hospitals and clinics. If you have been treated with any of these medications, you should contact your healthcare provider or pharmacist immediately, as the firm has initiated this voluntary recall to prevent potential infections.

Risk

The lack of assurance of sterility means these injectable and eye medications could contain microbial contamination; if a non-sterile drug is injected or placed in the eye, it can lead to serious, life-threatening infections or permanent vision loss.

What You Should Do

  1. Identify if you have any of the 18 affected products by checking the label for 'Premier Pharmacy Labs' and the following NDC numbers: 69623-131-12 (Atropine Sulfate), 69623-211-31 (Brilliant Blue), 69623-122-28 (Chlorpromazine), 69623-252-10 (Dexamethasone), 69623-185-10 (Droperidol), 69623-230-57, 69623-240-57, or 69623-107-57 (Isoproterenol), 69623-176-31 (Lidocaine/Phenylephrine), 69623-160-35 (Mitomycin), 69623-235-39 (Naloxone), 69623-234-15 (Neostigmine), 69623-104-10 (Orphenadrine), 69623-236-16 (Phenylephrine), 69623-106-61 (Riboflavin), 69623-232-39 (Sodium Bicarbonate), and 69623-239-15 or 69623-239-16 (Succinylcholine).
  2. Check the packaging for the expiration date; this recall applies to ALL lots of the listed products that are currently within their expiration date.
  3. Immediately stop using any affected medications and quarantine them to prevent accidental administration to patients.
  4. Contact your healthcare provider or pharmacist if you have concerns about medications you have already received or administered.
  5. Return any unused product to the place of purchase or pharmacy for a refund and contact Premier Pharmacy Labs for further instructions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe
Model:
Recall #: D-1411-2019
UPC Codes:
069623131126
Lot Numbers:
All lots remaining within expiry
Product: Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV
Model:
Recall #: D-1412-2019
UPC Codes:
269623211310
Lot Numbers:
All lots remaining within expiry
Product: ChlorproMAZINE HCL INJ, 25mg/mL, 1mL in a 5mL Sterile SDV
Model:
Recall #: D-1413-2019
UPC Codes:
769623122284
Lot Numbers:
All lots remaining within expiry
Product: Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe
Model:
Recall #: D-1414-2019
UPC Codes:
069623252104
Lot Numbers:
All lots remaining within expiry
Product: Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe
Model:
Recall #: D-1415-2019
UPC Codes:
069623185105
Lot Numbers:
All lots remaining within expiry
Product: Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag
Model:
Recall #: D-1416-2019
UPC Codes:
069623230577
Lot Numbers:
All lots remaining within expiry
Product: Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag
Model:
Recall #: D-1417-2019
UPC Codes:
069623240577
Lot Numbers:
All lots remaining within expiry
Product: Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag
Model:
Recall #: D-1418-2019
UPC Codes:
369623107573
Lot Numbers:
All lots remaining within expiry
Product: Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV
Model:
Recall #: D-1419-2019
UPC Codes:
669623176310
Lot Numbers:
All lots remaining within expiry
Product: Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV
Model:
Recall #: D-1420-2019
UPC Codes:
569623160350
Lot Numbers:
All lots remaining within expiry
Product: Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV
Model:
Recall #: D-1421-2019
UPC Codes:
669623235390
Lot Numbers:
All lots remaining within expiry
Product: Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe
Model:
Recall #: D-1422-2019
UPC Codes:
569623234150
Lot Numbers:
All lots remaining within expiry
Product: Orphenadrine Citrate Sterile Injectable Solution, 30mg/mL, 1mL Sterile Single-Use Syringe
Model:
Recall #: D-1423-2019
UPC Codes:
769623104105
Lot Numbers:
All lots remaining within expiry
Product: Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), 10mL Single-Dose Syringe
Model:
Recall #: D-1424-2019
UPC Codes:
869623236162
Lot Numbers:
All lots remaining within expiry
Product: Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle
Model:
Recall #: D-1425-2019
UPC Codes:
169623106619
Lot Numbers:
All lots remaining within expiry
Product: Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL), 50mL Sterile SDV
Model:
Recall #: D-1426-2019
UPC Codes:
869623232393
Lot Numbers:
All lots remaining within expiry
Product: SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe
Model:
Recall #: D-1427-2019
UPC Codes:
069623239150
Lot Numbers:
All lots remaining within expiry
Product: SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe
Model:
Recall #: D-1428-2019
UPC Codes:
969623239160
Lot Numbers:
All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83146
Status: Resolved
Manufacturer: Premier Pharmacy Labs Inc
Sold By: Hospitals; Clinics; Medical facilities
Manufactured In: United States
Units Affected: 18 products (745 syringes; 578 vials; 824 vials; 86 syringes; 2315 syringes; 606 bags; 1235 bags; 40 bags; 323 vials; 1834 irrigation vials; 6 vials; 4806 syringes; 4363 syringes; 1040 syringes; 125 dropper bottles; 13150 vials; 6423 syringes; 1721 syringes)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.