Drug Recall Terminated Historical recordClass II
Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.
- Reason
- Lack of Processing Controls.
- Recall initiated
- May 28, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Nationwide.
FDA Drug Recalls
Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.
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Drug Recall Terminated Historical recordClass II
Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.
- Reason
- Lack of Processing Controls.
- Recall initiated
- May 28, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Nationwide.
Drug Recall Terminated Historical recordClass I
AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32
- Reason
- Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Nationwide in the USA
Drug Recall Terminated Historical recordClass I
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31
- Reason
- Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Nationwide in the USA
Drug Recall Terminated Historical recordClass III
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
- Reason
- Failed Stability Specifications: Out of specification for viscosity.
- Recall initiated
- June 17, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Nationwide in the U.S.
Drug Recall Terminated Historical recordClass I
Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz. (474 mL), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16.
- Reason
- Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
- Recall initiated
- May 28, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Puerto Rico
Drug Recall Terminated Historical recordClass III
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
- Reason
- Failed Impurities/Degradation Specifications.
- Recall initiated
- May 22, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Nationwide within the United States
Drug Recall Terminated Historical recordClass II
Bisacodyl Suppositories, Brite Stock, Reese.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC:13668-577-10 Distributed by Torrent Pharma Inc., Basking Ridge, NJ 07920.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, 5 mg/1.5 mg per 5 mL, Rx Only, 16 FL. oz. (473 mL) bottle, NDC: 59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA 19057 USA.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only, 30 mL bottle, NDC 23155-317-51, Mfd for Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Cetirizine Hydrochloride Oral Solution, USP 1mg/mL, Fr Oral Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-07, b) NDC 13668-596-07, Manufactured by Bio-Pharm, Inc. Levittown, PA, For Torrent Pharma Inc., Basking Ridge, NJ 07920..
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton, NDC: 0904-7688-22, Distributed by Major Pharmaceuticals, Livonia MI 48152.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 Rectal Suppositories per carton, NDC: 0536-1389-12, Distributed by Rugby Laboratories, Livonia MI 48152 USA.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Hydrocortisone Acetate Suppositories, 25 mg, Rx Only, For rectal administration, a) 12 Adult Suppositories per carton, NDC: 59741-301-12, b) 24 Adult Suppositories per carton, NDC: 59741-301-24, Manufactured by Bio-Pharm Inc., Levittown PA 19057.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Memantine Hydrochloride Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz.. bottle, NDC: 13668-573-09, Manufactured By Bio-Pharm Inc., Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Memantine Hydrochloride Oral Solution, 2 mg/mL, 12 oz. bottle, NDC: 39328-551-12, Patrin Pharma
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Drug Recall Terminated Historical recordClass II
Lactulose Solution, USP 10 g/15 mL, For Oral or Rectal Administration, Rx Only, 16 FL. oz. Bottle, NDC:13668-574-10, Manufactured By Bio-Pharm, Levittown, PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920.
- Reason
- cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
- Recall initiated
- May 21, 2019
- Reported by FDA
- June 19, 2019
- Distribution
- Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.
Data last updated:
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.
