Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.

Class IIModerate

FDAMay 5, 2020Nationwide• Mylan Institutional LLC

Memantine Capsules (Harvard Drug) – Dissolution Failure (2020)

Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.

Class IIILow

FDAApr 24, 2020AL, FL, IA +3 more• The Harvard Drug Group

Esomeprazole Capsules (Dr. Reddy's) – Brown Pellets (2020)

Discoloration: product contains brown pellets

Class IIILow

FDAApr 24, 2020Nationwide• Dr. Reddy's Laboratories, Inc.

R.E.C.K. Solution (QuVa Pharma) – Particulate Matter (2020)

Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac

Class IIILow

FDAApr 23, 2020Nationwide• QuVa Pharma, Inc.

Infuvite Pediatric Kit (Sandoz) – Defective Container (2020)

Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins

Class IIModerate

FDAApr 21, 2020Nationwide• Sandoz, Inc

Ketorolac Injection (Fresenius Kabi) – Particulate Matter (2020)

Presence of Particulate Matter - found in reserve sample vials at the firm.

Class IIModerate

FDAApr 20, 2020Nationwide• Fresenius Kabi USA, LLC

Ketorolac Injection (Fresenius Kabi) – Particulate Matter (2020)

Presence of Particulate Matter - found in reserve sample vials at the firm.

Class IHigh

FDAApr 20, 2020Nationwide• Fresenius Kabi USA, LLC

Lisinopril Tablets (Lupin) – Product Mix-Up (2020)

Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.

Class IIModerate

FDAApr 20, 2020Nationwide• Lupin Pharmaceuticals Inc.

Ceftazidime Injection (B. Braun) – Stability Specification Failure (2020)

Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.

Class IHigh

FDAApr 18, 2020Nationwide• B. Braun Medical Inc

Energy Formula Multivitamins (Vitamin Shoppe) – packaging safety (2020)

This recall involves The Vitamin Shoppe's Energy Formula multivitamins in a white bottle with a blue, white, and gold label. Each bottle contains 90 tablets and has the code VS-3293 with the lot number 8102351 located on the bottom of the bottle.

CPSCApr 16, 2020Nationwide• The Vitamin Shoppe, of Secaucus, N.J.

Cefixime Oral Suspension (Lupin) – Subpotent Drug (2020)

Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

Class IIModerate

FDAApr 15, 2020Nationwide• Lupin Pharmaceuticals Inc.

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