Class I - Dangerous
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
💊
Prescription Drugs
💊 Drugs • 11,927 recalls
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
Dr. Reddy's Laboratories
Class I - Dangerous
Discoloration: product contains brown pellets
Class I - Dangerous
Defective Delivery System: Out of specification for mechanical peel and shear.
Class I - Dangerous
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Class I - Dangerous
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 I - Dangerous
Defective Delivery System: Out of specification for mechanical peel and shear.
Class I - Dangerous
Defective Delivery System: Out of specification for mechanical peel and shear.
Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
Aurobindo Pharma USA
Class I - Dangerous
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Class I - Dangerous
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
Paregoric Alternate Elixir 300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Progesterone/Versa Base 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Levothyroxin (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control
Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Class I - Dangerous
Lack of Processing Control