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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pharmacy Innovations Injectable and Ophthalmic Drugs Recalled for Sterility Risks

Agency Publication Date: January 26, 2023
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Summary

Pharmacy Innovations has recalled numerous injectable, ophthalmic (eye), and inhalation drugs due to a lack of assurance of sterility. An FDA inspection revealed insanitary conditions at the manufacturing facility in Erie, Pennsylvania, which could compromise the safety of these sterile medications. The recall covers a wide range of compounded products, including hormones (testosterone, progesterone), vitamins (Methylcobalamin, Vitamin D3), and specialty treatments like Semaglutide. While no incidents or injuries have been reported, medications administered via injection or applied to the eyes must be sterile to prevent serious illness.

Risk

Using medications that lack sterility assurance poses a serious risk of infection. Because these drugs are injected into the body or applied directly to the eyes, any contamination could bypass natural defenses and lead to severe, potentially life-threatening medical complications.

What You Should Do

  1. This recall affects various injectable, eye (ophthalmic), and inhalation drugs manufactured by Pharmacy Innovations at their facility in Erie, Pennsylvania.
  2. Identify your medication by checking the brand name 'Pharmacy Innovations' and the specific product name and dosage listed on the vial, droptainer, or syringe. Check the lot number printed on your product's label. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Pharmacy Innovations for further instructions.
  4. Contact Pharmacy Innovations directly for further instructions regarding the return of these medications.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dutasteride Injectable (1.5ML VIAL)
Variants: 0.1%, Rx Only
Model:
D-0185-2023
Lot Numbers:
20221012@21
t20221025@32
t20221109@7
Product: Chlorpheniramine/Hyoscyamine Injectable (1ML)
Variants: 10MG/0.25MG/ML, Rx Only
Model:
D-0186-2023
Lot Numbers:
t20221026@41
Product: Hydroxocobalamin Injectable (2ML vial)
Variants: 25MG/ML, Rx Only
Model:
D-0187-2023
Lot Numbers:
t20221025@33
Product: Methylcobalamin Injectable (1ML vial)
Variants: 1MG/ML, 3MG/ML, 5MG/ML, Rx Only
Model:
D-0188-2023
Lot Numbers:
t20221021@36
t20221025@32
t20221025@33
Product: Minoxidil Injectable (1.5ML vial)
Variants: 0.75%, Rx Only
Model:
D-0189-2023
Lot Numbers:
t20221011@36
Product: 5-Fluorouracil Ophthalmic (droptainer)
Variants: 1%, 2.5ML, 5ML, Rx Only
Model:
D-0190-2023
Lot Numbers:
t20221019@52
t20221013@13
Product: Acetylcysteine Ophthalmic Solution
Variants: 10%, Rx Only
Model:
D-0191-2023
Lot Numbers:
t20221011@36
t20221108@24
Product: Albuterol Inhalation Solution (3ML tube)
Variants: 0.083%, PF/SULFURIC ACID/DYE FREE, Rx Only
Model:
D-0192-2023
Lot Numbers:
t20221011@36
t20221108@24
Product: Apomorphine HCL Injectable (10ML vial)
Variants: 2MG/ML, Rx Only
Model:
D-0193-2023
Lot Numbers:
t20221108@46
Product: Atropine sulfate Ophthalmic (1ML dropper)
Variants: 0.05%, 0.01%, Rx Only
Model:
D-0194-2023
Lot Numbers:
t20221025@32
t20221025@33
Product: BSS Plus/Lidocaine Opth Injectable (1ML syringe)
Variants: 1%, Rx Only
Model:
D-0195-2023
Lot Numbers:
t20221004@47
Product: Buprenorphine HCL Injectable (25ML vial)
Variants: 0.9 MG/ML, Rx Only
Model:
D-0196-2023
Lot Numbers:
t20221118@33
Product: Ceftazidime Intravitreal Injectable (1ML vial)
Variants: 22.5 MG/ML, 2.25MG/0.1ML, Rx Only
Model:
D-0197-2023
Lot Numbers:
t20221028@11
Product: Cholecalciferol (Vitamin D3) Injectable
Variants: 100,000U/ML, Rx Only
Model:
D-0198-2023
Lot Numbers:
t20221130@14
Product: Clindamycin/EDTA Calcium Irrigation (30ML syringe)
Variants: 4.1667MG/0.333MG/ML, Rx Only
Model:
D-0199-2023
Lot Numbers:
t20221109@41
Product: Cyclosporine (A) Ophthalmic Solution
Variants: 0.1%, 0.2%, 1%, 2%, Corn oil - 1%, Rx Only
Model:
D-0200-2023
Lot Numbers:
t20221109@43
t20221108@27
t20221011@41
t20221024@3
t20221104@37
t20221025@32
t20221025@33
t20221013@15
t20221017@5
Product: Dexamethasone Injectable/Ophthalmic
Variants: 16MG/ML (3ML vial), 24MG/ML, PF 0.1% (1ML dropper), Rx Only
Model:
D-0201-2023
Lot Numbers:
t20221116@36
t20221117@11
t20221108@87
Product: Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF Injectable (1ML vial)
Variants: 250MG/100MG/1MG/ML, Rx Only
Model:
D-0202-2023
Lot Numbers:
t20221012@64
t20221114@18
Product: Edetate Calcium Disodium Injectable (30ML vial)
Variants: 400MG/ML, Rx Only
Model:
D-0203-2023
Lot Numbers:
t20221013@15
Product: Edetate Disodium (Vet) Ophthalmic Solution (3ML droptainer)
Variants: 1%, Rx Only
Model:
D-0204-2023
Lot Numbers:
t20221116@36
t20221005@3
t20221021@32
t20221110@60
t20221130@10
Product: Estradiol Ophthalmic Solution
Variants: 0.05%, Rx Only
Model:
D-0205-2023
Lot Numbers:
t20221021@9
Product: Estradiol Cypionate/Testosterone Cypionate Injectable
Variants: 2MG/50MG/ML (1.5ML vial), 2MG/25MG/ML (1ML vial), 5MG/ML, SS OIL, CS OIL, GS OIL, Rx Only
Model:
D-0206-2023
Lot Numbers:
t20221109@7
t20221027@6
t20221010@8
t20221116@36
t20221111@45
t20221026@41
Product: Ethyl Alcohol 95% Injectable (5ML vial)
Variants: Rx Only
Model:
D-0207-2023
Lot Numbers:
t20221013@15
Product: Flurbiprofen Ophthalmic Solution (3ML droptainer)
Variants: Corn Oil 0.04%, Rx Only
Model:
D-0208-2023
Lot Numbers:
t20221116@36
Product: Gentamicin Bladder Irrigation (Syringe)
Variants: 0.08MG/ML, 0.48MG/ML, 0.64MG/ML, 25ML, 30ML, 60ML, Rx Only
Model:
D-0209-2023
Lot Numbers:
t20221117@11
t20221116@36
t20221011@36
t20221108@24
t20221125@30
t20221020@64
Product: Glutathione L Reduced Inhalation/Injectable
Variants: 100MG/ML, 200MG/ML, 220MG/ML, 500MG/ML, PF, Rx Only
Model:
D-0210-2023
Lot Numbers:
t20221129@68
t20221025@32
t20221025@33
t20221114@27
t20221021@40
t20221116@36
Product: Glycerin Injectable (15ML vial)
Variants: 72% (W/V), Rx Only
Model:
D-0211-2023
Lot Numbers:
t20221117@11
Product: Glycerin Sterile Injectable (Vial)
Variants: 99%, 2ML, 5ML, Rx Only
Model:
D-0212-2023
Lot Numbers:
t20221004@24
t20221115@20
t20221116@36
Product: Glycerin/Lidocaine HCL/Epinephrine Injectable (10ML vial)
Variants: 31%(V/V)/0.17%/0.00017%, 48.7%(W/V)/0.67%/0.00067%, Rx Only
Model:
D-0213-2023
Lot Numbers:
t20221116@36
t20221117@11
Product: Heparin/Lidocaine HCL/Sodium Bicarbonate Irrigation (20ML syringe)
Variants: 100U/2MG/16.8MG/ML, Rx Only
Model:
D-0214-2023
Lot Numbers:
t20221011@36
t20221108@24
Product: Hydroxocobalamin-PF Injectable (1ML vial)
Variants: 1MG/ML, Rx Only
Model:
D-0215-2023
Lot Numbers:
t20221116@36
t20221117@11
t20221111@61
Product: Ketamine Injectable (10ML vial)
Variants: 50MG/ML, Rx Only
Model:
D-0216-2023
Lot Numbers:
t20221031@55
Product: Levemir-STS Injectable (1ML vial)
Variants: 100U/ML, Rx Only
Model:
D-0217-2023
Lot Numbers:
t20221116@36
Product: Lidocaine-PF Injectable (5ML vial)
Variants: 5%, Rx Only
Model:
D-0218-2023
Lot Numbers:
t20221011@36
t20221108@24
Product: Magnesium Chloride Hexahydrate-PF Injectable (5ML vial)
Variants: 200MG/ML, Rx Only
Model:
D-0219-2023
Lot Numbers:
t20221011@36
Product: Methion/Inosit/Choline Multi-Vitamin Injectable (1ML vial)
Variants: Various Formulations, Rx Only
Model:
D-0220-2023
Lot Numbers:
t20221011@25
t20221025@48
t20221115@36
Product: Methotrexate Intravitreal Injectable (1ML vial)
Variants: 4MG/ML, 400MCG/0.1ML, Rx Only
Model:
D-0221-2023
Lot Numbers:
t20221011@36
Product: Methylcobalamin Injectable (Vial)
Variants: 12.5MG/ML, 25MG/ML, 3MG/ML, 5MG/ML, PF, Rx Only
Model:
D-0222-2023
Lot Numbers:
t20221011@25
t20221011@37
t20221018@35
t20221121@29
t20221116@36
Product: Mitomycin Ophthalmic Solution/Vial
Variants: 0.2MG/ML, Rx Only
Model:
D-0223-2023
Lot Numbers:
t20221004@8
t20221011@36
Product: Mitomycin Ophthalmic Solution/Vial
Variants: 0.4MG/ML, Rx Only
Model:
D-0224-2023
Lot Numbers:
t20221108@20
t20221026@25
t20221116@36
Product: NADH Injectable (10ML vial)
Variants: 10MG/ML, Rx Only
Model:
D-0225-2023
Lot Numbers:
t20221108@46
Product: Papaverine/Phentolamine Injectable (1ML vial)
Variants: 30MG/0.5MG/ML, 30MG/1MG/ML, 30MG/2MG/ML, 30MG/3MG/ML, 30MG/5MG/ML, Rx Only
Model:
D-0226-2023
Lot Numbers:
t20221011@7
t20221020@34
t20221018@58
t20221013@15
t20221104@39
Product: PE1/Papaverine/Atropine/Chlorpromazine Injectable (1ML vial)
Variants: Various Strengths, Rx Only
Model:
D-0227-2023
Lot Numbers:
t20221025@7
t20221116@36
20221114@41
t20221117@5
Product: PE1/Papaverine/Phentolamine Injectable (1ML vial)
Variants: Numerous Formulations, Rx Only
Model:
D-0228-2023
Lot Numbers:
t20221018@32
t20221108@89
t20221013@18
t20221031@11
t20221010@18
t20221101@1
20221108@18
t20221101@3
t20221027@32
t20221123@10
t20221013@15
t20221003@37
t20221021@32
t20221108@3
t20221011@36
t20221108@24
t20221021@43
t20221026@5
t20221123@15
t20221111@58
t20221116@36
t20221128@2
t20221116@57
t20221007@33
t20221111@39
t20221128@45
t20221104@34
t20221018@61
t20221111@19
t20221108@64
t20221117@11
t20221114@21
t20221108@33
t20221010@22
t20221004@44
t20221121@49
Product: Phenol Injectable (10ML vial)
Variants: 10%, Rx Only
Model:
D-0229-2023
Lot Numbers:
20221017@50
Product: Phosphatidylcholine/Deoxycholic Acid Injectable (10ML vial)
Variants: 50MG/50MG/ML, 5%/5%, Rx Only
Model:
D-0230-2023
Lot Numbers:
t20221025@32
Product: Polidocanol Injectable (30ML vial)
Variants: 50MG/ML, 5%, Rx Only
Model:
D-0231-2023
Lot Numbers:
t20221025@32
Product: Polyhexamethylene Biguanide Ophthalmic Solution (10ML droptainer)
Variants: 0.2MG/ML, 0.2%, Rx Only
Model:
D-0232-2023
Lot Numbers:
t20221025@32
Product: Progesterone-GS Oil Injectable (2ML vial)
Variants: 100MG/ML, Rx Only
Model:
D-0233-2023
Lot Numbers:
t20221116@36
Product: Prostaglandin (PE1) Injectable (Vial)
Variants: Various Strengths, Rx Only
Model:
D-0234-2023
Lot Numbers:
t20221027@29
t20221020@25
t20221109@17
t20221118@8
t20221129@68
t20221027@11
t20221010@24
t20221010@61
t20221005@2
t20221024@22
t20221116@36
t20221004@12
Product: Scopolamine Hydrobromide Ophthalmic Solution
Variants: 0.25%, Rx Only
Model:
D-0235-2023
Lot Numbers:
t20221111@37
Product: Semaglutide Injectable (0.5ML vial)
Variants: 0.5MG/ML, 1MG/ML, 2MG/ML, 4MG/ML, 5.4MG/ML, Rx Only
Model:
D-0236-2023
Lot Numbers:
t20221026@52
t20221102@11
t20221004@44
t20221116@36
t20221011@36
Product: Tacrolimus Ophthalmic Solution/Dropper
Variants: 0.02%, 0.03%, 0.1%, Corn Oil, Vet, Rx Only
Model:
D-0237-2023
Lot Numbers:
t20221011@25
t20221011@55
t20221020@26
t20221104@44
t20221027@6
20221019@44
t20221026@41
Product: Testosterone Ophthalmic Ointment/Injectable
Variants: 3% Ointment, Testosterone Cypionate Formulations, Rx Only
Model:
D-0238-2023
Lot Numbers:
t20221011@42
t20221011@36
t20221116@36
t20221117@11
t20221108@24
t20221007@33
t20221129@68
t20221014@45
t20221116@54
t20221116@55
t20221024@36
t20221004@38
t20221109@46
t20221027@6
t20221010@8
t20221109@42
t20221115@21
t20221010@50
t20221115@19
t20221010@25
t20221017@7
t20221117@23
t20221103@11
t20221003@7
t20221024@58
t20221018@10
t20221011@1
t20221121@43
t20221027@38
Product: Thiamine/Riboflavin/Niacinamide Multi-Vitamin Injectable
Variants: Various Formulations, Rx Only
Model:
D-0239-2023
Lot Numbers:
t20221116@36
t20221121@42
t20221021@32
Product: Tobramycin Fortified Ophthalmic Solution
Variants: 15MG/ML, Rx Only
Model:
D-0240-2023
Lot Numbers:
t20221104@17
Product: Vancomycin Fortified Ophthalmic Solution
Variants: 10MG/ML, 14MG/ML, 25MG/ML, 50MG/ML, STS, Rx Only
Model:
D-0241-2023
Lot Numbers:
t20221122@15
t20221110@28
t20221027@33
t20221020@5
Product: Vitamin D3 Injectable (1ML vial)
Variants: 10,000IU/ML, 50,000IU/ML, PF, Aqueous, Ethyl Oleate, Rx Only
Model:
D-0242-2023
Lot Numbers:
t20221017@25
t20221013@15
Product: Voriconazole Ophthalmic Solution (10ML dropper)
Variants: 10MG/ML, Rx Only
Model:
D-0243-2023
Lot Numbers:
t20221025@32

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91332
Status: Resolved
Manufacturer: Pharmacy Innovations
Sold By: Pharmacy Innovations
Manufactured In: United States
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 ยท 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.