Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Class IHigh

FDAMay 11, 2021Nationwide• Yamtun7

Vitamin D3 Tablets (Twenty-First Century) – mislabeled dosage (2021)

A small quantity of bottles of Vitamin D3 125 mcg ((5000 IU) 100 ct. were mislabeled as Vitamin D3 25 mcg (1000 IU). Secondary labeling on the bottles (back label) is correctly labeled as Vitamin D3 125 mcg (5000 IU).

Class IIModerate

FDAMay 7, 2021AZ• Twenty-First Century Healthcare, Inc

Cequa Eye Solution (Sun Pharmaceutical) – Potency Issue (2021)

Subpotent and Presence of Particulates .

Class IIILow

FDAMay 7, 2021Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

MCT Oil Powder (BUBS Naturals) – undeclared milk (2021)

Undeclared Allergen

Firm was notified by supplier of Medium Chain Triglycerides (MCT) that it contained undeclared milk allergens.

Class IHigh

FDAMay 7, 2021Nationwide• Slayer Forever, LLC dba BUBS Naturals

BusPIRone Tablets (Oxford Pharma) – Foreign Tablets (2021)

Presence of Foreign Tablets/Capsules

Class IIModerate

FDAMay 5, 2021Nationwide• Oxford Pharmaceuticals, LLC

Micardis Tablets (Boehringer) – Subpotent Drug (2021)

Subpotent Drug

Class IIModerate

FDAMay 4, 2021AR, CO, CT +8 more• Boehringer Ingelheim Pharmaceuticals, Inc.

Atorvastatin Tablets (Dr. Reddy's) – Impurity Specs (2021)

Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities

Class IIILow

FDAMay 4, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Metformin Tablets (Sun Pharmaceutical) – Foreign Substance (2021)

Presence of foreign substance: identified as activated carbon.

Class IIModerate

FDAMay 4, 2021Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Biotin Collagen Capsules (Bloommy) – Undeclared Fish (2021)

Undeclared Allergen

Dietary supplement contains undeclared fish collagen

Class IIModerate

FDAMay 4, 2021Nationwide• bloommy Inc.

Lidocaine Injection (Pfizer) – Label Mix-Up (2021)

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

Class IHigh

FDAMay 3, 2021Nationwide• PFIZER, INC

Bupivacaine Injection (Pfizer) – Label Mix-Up (2021)

Class IHigh

FDAMay 3, 2021Nationwide• PFIZER, INC

Thiamine Injection (Mylan) – Labeling Error (2021)

Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.

Class IIILow

FDAMay 3, 2021Nationwide• Mylan Institutional LLC

Sterile Water for Inj. (Pfizer) – Insect Contamination (2021)

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

Class IIModerate

FDAMay 3, 2021Nationwide• Pfizer Inc.

NP Thyroid 120 (Acella) – Subpotent Medication (2021)

Subpotent Drug

Class IHigh

FDAApr 29, 2021Nationwide• Acella Pharmaceuticals, LLC

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