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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 14601–14620 of 17,832 recalls

Class ITerminated

Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869 (973) 328-8756.

Pharmacy Creations

Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.

September 5, 2014 · DrugView details →
Class IITerminated

Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02

Hospira Inc.

Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.

September 4, 2014 · DrugView details →
Class IITerminated

Dermatend Ultra, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.34 OZ (10g) container, Solace International, Inc., Reno, NV 89509, USA

Solace International Inc

Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.

August 28, 2014 · DrugView details →
Class IITerminated

Dermatend Original, mole, wart and skin tag remover, For external use only, Ingredient: Distilled Water, Sanguinaria Canadensis, Vegetable Glycerin, Butter of Zinc, Germall Plus, 0.17 OZ (5g) container, Solace International, Inc., Reno, NV 89509, USA

Solace International Inc

Labeling: Labeling Bears Unapproved Claims; Dermatend is not FDA approved and therefore has not been shown to be safe and effective for the uses suggested in the labeling.

August 28, 2014 · DrugView details →
Class IITerminated

Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.

Alvogen, Inc

Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.

August 28, 2014 · DrugView details →
Class IITerminated

FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g)

Fougera Pharmaceuticals Inc.

Failed Stability Specifications: The lots of Fluocinonide Gel USP, 0.05% recalled, may not meet the requirements for residual solvents as outlined in USP <467>.

August 28, 2014 · DrugView details →
Class IITerminated

Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Quad mix, 9 mg/1 mg/10 mcg/0.1 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial with silver crimp top and sold under the Martin Avenue Pharmacy brand.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Hyaluronidase injection solution (PF) 150 U/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Benzalkonium chloride water for injection packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Voriconazole 10 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Fentanyl injectable 6000 mcg/mL packaged in 30 mLor 60 mL syringes, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Quad mix 2, 12 mg/1 mg/25 mcg/0.25 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Quad mix, 18 mg/0.2 mg/10 mcg/0.02 mg/mL (papaverine, phentolamine mesylate, alprostadil, atropine) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Phenol 10% injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Methylcobalamin 25 mg/mL injectable packaged in an amber glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Tri-mix T50, 8.825 mg/0.29 mg/2.95 mcg/mL (papaverine, phentolamine mesylate, alprostadil) injectable packaged in a clear glass injectable vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
Class IITerminated

Vancomycin 50 mg/mL opthalmic solution packaged in an opaque squeeze bottle eye dropper, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL.

Martin Avenue Pharmacy, Inc.

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

August 27, 2014 · DrugView details →
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