Prescription medicine recalls

Fresenius Kabi Compounding, LLC — vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

Lack of Assurance of Sterility

Fresenius Kabi Compounding, LLC — acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56

Lack of Assurance of Sterility

Fresenius Kabi Compounding, LLC — thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.

Lack of Assurance of Sterility

Fresenius Kabi Compounding, LLC — ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

Lack of Assurance of Sterility

SOMERSET THERAPEUTICS LLC — Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only

Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were…

Annora Pharma Private Limited — Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only

Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg

Pro Numb Tattoo Numbing Spray LLC — Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle

cGMP deviations

Pro Numb Tattoo Numbing Spray LLC — Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle

cGMP deviations

Teva Pharmaceuticals USA, Inc — Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

Failed Dissolution Specifications

Teva Pharmaceuticals USA, Inc — Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

Failed Dissolution Specifications

Teva Pharmaceuticals USA, Inc — Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

Failed Dissolution Specifications

Teva Pharmaceuticals USA, Inc — Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

Failed Dissolution Specifications

SUN PHARMACEUTICAL INDUSTRIES INC — Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 303 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1303-01.

Presence of Foreign substance - potential presence of metal particulate matter

F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 200 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1200-43.

Presence of Foreign substance - potential presence of metal particulate matter

Granules Pharmaceuticals Inc. — Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only

Presence of Foreign Tablets/Capsules

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone 87.5mg, Triamcinolone Acetonide17.5 mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6087-32.

Presence of Foreign substance - potential presence of metal particulate matter

F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.

Presence of Foreign substance - potential presence of metal particulate matter

F.H. INVESTMENTS, Inc. (dba Asteria Health) — ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.

Presence of Foreign substance - potential presence of metal particulate matter

F.H. INVESTMENTS, Inc. (dba Asteria Health) — Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.

Presence of Foreign substance - potential presence of metal particulate matter