Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Drugs Recalls
Prescription and over-the-counter medications
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
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.
Defective Delivery System: Out of specification for mechanical peel and shear.
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
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
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
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
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
Lack of Processing Control
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
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
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
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
Lack of Processing Control
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
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
Lack of Processing Control
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL
The Medicine Shoppe Pharmacy
Lack of Processing Control