Manufacturer profile
Best Choice
Pharmaceutical company2 products tracked
2
products tracked
214,547
total reports
81
recalls on record
67.4%
serious overall
Products
showing 2 of 2
| Product | Approved | Reports ↓ | Top signal | Recalls |
|---|---|---|---|---|
| 1972 | 195,250 | Infusion related reaction | 49 | |
| — | 19,297 | Infusion related reaction | 32 |
Recall history · 29 on record
| Date | Class | Reason | Firm |
|---|---|---|---|
| Mar 26, 2025 | II | CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit | Chattem Inc |
| Mar 4, 2025 | II | CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. | Chattem Inc |
| Dec 12, 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| Dec 12, 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| Dec 12, 2024 | III | Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID. | Akron Pharma, Inc. |
| Apr 28, 2023 | II | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile. | Central Admixture Pharmacy Services, Inc. |
| Dec 27, 2022 | II | Lack of sterility assurance | Sentara Infusion Services |
| Jun 23, 2022 | II | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. |
| Apr 13, 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| Jan 24, 2022 | II | cGMP deviations | Ultra Seal Corporation |
| Mar 15, 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| Jun 24, 2019 | II | Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | H J Harkins Company Inc dba Pharma Pac |
| Jun 12, 2019 | II | Lack of Assurance of Sterility | Infusion Options, Inc. |
| May 31, 2019 | II | cGMP Deviations: Products may have microbial contamination. | Geritrex, LLC |
| May 21, 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| May 21, 2019 | II | cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii). | Torrent Pharma Inc |
| Feb 9, 2018 | II | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC |
| Aug 30, 2017 | II | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Mid Valley Pharmaceutical |
| Aug 30, 2017 | II | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia. | Mid Valley Pharmaceutical |
| Jan 5, 2017 | III | Subpotent | InnovaGel |
| May 28, 2015 | II | Lack of Assurance of Sterility: Sterility of product is not assured. | Lincare, Inc. |
| Mar 6, 2015 | II | Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. | Fusion Pharmaceuticals, LLC |
| Dec 26, 2014 | II | Lack of sterility assurance. | Walgreens Infusion Services |
| Apr 25, 2014 | III | Presence of Precipitate; small amounts of diphenhydramine precipitated out of solution | Prestige Brands Holdings |
| Apr 15, 2014 | III | Presence of Precipitate: Small amounts of diphenydramine and mannitol precipitated out of solution. | P&L Developments, LLC |
| Jul 2, 2013 | II | Labeling: Label Mixup; diphenhydrAMINE HCl, Tablet, 25 mg may be potentially mislabeled as ATORVASTATIN CALCIUM, Tablet, 40 mg, NDC 00378212177, Pedigree: AD33897_10, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: W002774, EXP: 6/6/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003511, EXP: 6/21/2014; VENLAFAXINE, Tablet, 25 mg | Aidapak Services, LLC |
| Jun 18, 2013 | II | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health |
| May 29, 2013 | II | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes | Lowlite Investments, Inc. D/B/A Olympia Pharmacy |
| May 25, 2012 | II | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.
Registration status
Some products from Best Choice are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.