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Akron Pharma, Inc. FDA Recalls
11 recalls on file across drugs, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117Class IIIDec 12, 2024Labeling: Not Elsewhere Classified: Tablets/Capsules imprint |
| Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, FClass IIIDec 12, 2024Labeling: Not Elsewhere Classified: Tablets/Capsules imprint |
| Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46,Class IIIDec 12, 2024Labeling: Not Elsewhere Classified: Tablets/Capsules imprint |
| Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 USClass IIIDec 12, 2024Labeling: Not Elsewhere Classified: Tablets/Capsules imprint |
| Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ Class IIIDec 12, 2024Labeling: Not Elsewhere Classified: Tablets/Capsules imprint |
| Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W BClass IIIDec 12, 2024Labeling: Not Elsewhere Classified: Tablets/Capsules imprint |
| Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Class IIIDec 12, 2024Labeling: Not Elsewhere Classified: Tablets/Capsules imprint |
| OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron PharClass IIOct 15, 2024CGMP Deviations |
| DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Pharma Inc. Fairfield NJ 07004, NDC 71399-282Class IIIFeb 17, 2023Labeling: Incorrect or Missing Lot and/or Exp Date |
| Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (Class IIIAug 4, 2022Failed Tablet/Capsule Specifications: Imprint "AP 325" is mi |
| Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024Class IIIAug 4, 2022Failed Tablet/Capsule Specifications: Imprint "AP 325" is mi |