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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 4401–4420 of 17,755 recalls

Class IIITerminated

Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41

MACLEODS PHARMA USA, INC

Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

October 18, 2021 · DrugView details →
Class IITerminated

Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05

Golden State Medical Supply Inc.

Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle

October 14, 2021 · Drug
View details →
Class IITerminated

Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05

Golden State Medical Supply Inc.

Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity

October 14, 2021 · DrugView details →
Class IIITerminated

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →
Class IIITerminated

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →
Class IIITerminated

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →
Class IIITerminated

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →
Class IIITerminated

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →
Class IIITerminated

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →
Class IIITerminated

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →
Class IIITerminated

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

October 13, 2021 · DrugView details →
Class IITerminated

B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

October 12, 2021 · DrugView details →
Class IITerminated

ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

October 12, 2021 · DrugView details →
Class IITerminated

TRI-TEST 200 (CY50%-EN37.5%-PR12.5%) INJ #1 200MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

October 12, 2021 · DrugView details →
Class IITerminated

TEST CYPIONATE 200MG/ANASTROZOLE 1MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

October 12, 2021 · DrugView details →
Class IITerminated

ULTRA-TEST (CYP 80%/PROP 20%) 200MG/ML INJ #1 200MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

October 12, 2021 · DrugView details →
Class IITerminated

TESTOSTERONE CYPIONATE 200MG/ML INJ #2 IN SESAME OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

October 12, 2021 · DrugView details →
Class IITerminated

TEST CYPIONATE 200MG/ANASTROZOLE 0.5MG/DUTASTERIDE 0.5MG/ML IN OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

October 12, 2021 · DrugView details →
Class ITerminated

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

Teligent Pharma, Inc.

Superpotent Drug

October 12, 2021 · DrugView details →
Class IITerminated

IC B COMPLEX INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247

Vita Pharmacy, LLC dba Talon Compounding Pharmacy

Lack of assurance of sterility

October 12, 2021 · DrugView details →
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