Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-313-2016 | 09-03-2015 | LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 vial | Class II | Terminated |
| D-327-2016 | 09-03-2015 | Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 5 vials | Class II | Terminated |
| D-301-2016 | 09-03-2015 | BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 5 vials | Class II | Terminated |
| D-323-2016 | 09-03-2015 | QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 vial | Class II | Terminated |
| D-320-2016 | 09-03-2015 | Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 50 vials | Class II | Terminated |
| D-329-2016 | 09-03-2015 | Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 2 vials | Class II | Terminated |
| D-315-2016 | 09-03-2015 | Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 2 vials | Class II | Terminated |
| D-299-2016 | 09-03-2015 | 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 4 vials | Class II | Terminated |
| D-328-2016 | 09-03-2015 | Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 261 vials | Class II | Terminated |
| D-324-2016 | 09-03-2015 | Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 7 vials | Class II | Terminated |
| D-317-2016 | 09-03-2015 | Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 8 prefilled syringes | Class II | Terminated |
| D-303-2016 | 09-03-2015 | Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 2 ointment tubes | Class II | Terminated |
| D-305-2016 | 09-03-2015 | Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 dropper bottle | Class II | Terminated |
| D-311-2016 | 09-03-2015 | HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 21 vials and 80 prefilled syringes | Class II | Terminated |
| D-318-2016 | 09-03-2015 | Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 30 prefilled syringes | Class II | Terminated |
| D-332-2016 | 09-03-2015 | TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 6 vials | Class II | Terminated |
| D-306-2016 | 09-03-2015 | HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 49 vials | Class II | Terminated |
| D-335-2016 | 09-03-2015 | TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 vial | Class II | Terminated |
| D-312-2016 | 09-03-2015 | LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 76 vials | Class II | Terminated |
| D-322-2016 | 09-03-2015 | Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 2 vials | Class II | Terminated |
| D-336-2016 | 09-03-2015 | TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 vial | Class II | Terminated |
| D-309-2016 | 09-03-2015 | HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 vial | Class II | Terminated |
| D-333-2016 | 09-03-2015 | TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 5 vials | Class II | Terminated |
| D-316-2016 | 09-03-2015 | Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 28 prefilled syringes | Class II | Terminated |
| D-331-2016 | 09-03-2015 | Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 vial | Class II | Terminated |
| D-300-2016 | 09-03-2015 | 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 35 vials | Class II | Terminated |
| D-302-2016 | 09-03-2015 | Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 7 dropper bottles | Class II | Terminated |
| D-298-2016 | 09-03-2015 | Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 2 dropper bottles | Class II | Terminated |
| D-330-2016 | 09-03-2015 | Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 20 vials | Class II | Terminated |
| D-319-2016 | 09-03-2015 | MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 vial | Class II | Terminated |
| D-308-2016 | 09-03-2015 | HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 2 vials | Class II | Terminated |
| D-307-2016 | 09-03-2015 | HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 2 vials | Class II | Terminated |
| D-314-2016 | 09-03-2015 | Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 10 prefilled syringes | Class II | Terminated |
| D-321-2016 | 09-03-2015 | Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 vial | Class II | Terminated |
| D-325-2016 | 09-03-2015 | Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 64 vials | Class II | Terminated |
| D-334-2016 | 09-03-2015 | TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 2 vials | Class II | Terminated |
| D-310-2016 | 09-03-2015 | HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 1 vial | Class II | Terminated |
| D-326-2016 | 09-03-2015 | sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / 2 vials | Class II | Terminated |
| D-304-2016 | 09-03-2015 | DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614. | Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs. | Kalman Health & Wellness, Inc. dba Essential Wellness Pharma / a) 720 vials; b) 4 vials | Class II | Terminated |
| D-1816-2015 | 09-02-2015 | 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch. | Baxter Healthcare Corporation / 139,104 Bags | Class II | Terminated |
| D-1418-2015 | 08-31-2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05 | Falied pH specification | Oasis Medical, Inc. / 909 cartons | Class III | Terminated |
| D-1832-2015 | 08-28-2015 | LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy, Birmingham, AL 35244 | Subpotent Drug: trace amounts of methylcobalamin in compounded drug. | Eagle Pharmacy, Inc. / 104 vials | Class II | Terminated |
| D-0230-2016 | 08-27-2015 | MIRACLE DIET 30 capsules, 30-count bottle, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 7 538073516768. | Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug. | The One Minute Miracle Inc / 1 bottle | Class I | Ongoing |
| D-0229-2016 | 08-27-2015 | MIRACLE ROCK 48 capsules, packaged in 2 x 2-count blisters, 4-count capsules per carton, Manufactured Exclusively For: The One Minute Miracle Inc., UPC 0911312397354. | Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug. | The One Minute Miracle Inc / 688 cartons | Class I | Ongoing |
| D-1815-2015 | 08-25-2015 | 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02 Package NDCs: 0409-4713-12; 0409-4713-26; 0409-4713-02; 0409-4713-72; 0409-4713-62; 0409-4713-75; 0409-4713-65; 0409-4713-42; 0409-4713-25; 0409-4713-32; 0409-4278-16; 0409-4278-01; 0409-4279-16; 0409-4279-02; 0409-4776-10; 0409-4776-01; 0409-4282-11; 0409-4282-25; 0409-4282-01; 0409-4282-12; 0409-4282-02; 0409-4277-16; 0409-4277-01; 0409-4277-17; 0409-4277-02; 0409-4276-16; 0409-4276-01; 0409-4276-17; 0409-4276-02; 0409-4275-16; 0409-4275-01 | Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials. | Hospira, Inc. / 100,200 Vials | Class II | Ongoing |
| D-0009-2016 | 08-25-2015 | Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326. | Lack of Assurance of Sterility: Failed preservative effectiveness testing | Apotex Inc. / 5,520 bottles (Lot MF0537), 2,828 bottles (Lot MF8090), and 20,454 bottles (Lot MF0532) | Class II | Terminated |
| D-1819-2015 | 08-24-2015 | FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0. | Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. | Allergan Sales, LLC / 28,292 tubes | Class II | Terminated |
| D-1820-2015 | 08-24-2015 | BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9. | Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. | Allergan Sales, LLC / 337 tubes | Class II | Terminated |
| D-0969-2016 | 08-24-2015 | Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0966-2016 | 08-24-2015 | The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0964-2016 | 08-24-2015 | MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0962-2016 | 08-24-2015 | The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers. Manufactured by TPC, LLC, www.thepeopleschemist.com. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0967-2016 | 08-24-2015 | TruTrim (product not labeled) | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0970-2016 | 08-24-2015 | Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0972-2016 | 08-24-2015 | Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0968-2016 | 08-24-2015 | Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0961-2016 | 08-24-2015 | Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0963-2016 | 08-24-2015 | Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0973-2016 | 08-24-2015 | Xcellerator (product not labeled) | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0971-2016 | 08-24-2015 | Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-0164-2016 | 08-24-2015 | Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distributed by: Truxton Inc. Bellmawr, NJ 08031, Manufactured for: Blu Caribe Dorado, PR 00646 USA, NDC 0463-6000-50 (top panel) NDC 24658-312-05 (side panel) | Labeling: Wrong Bar Code | C. O. Truxton / 287 bottles | Class II | Terminated |
| D-1817-2015 | 08-24-2015 | Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz (3.5 g) tubes (NDC 0023-0312-04) UPC 3 0023-0312-04 2 and b) Net wt. 0.25 oz (7 g) tubes (NDC 0023-0312-07) UPC 3 0023-0312-07 3, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612. Package NDCs: 0023-0312-04; 0023-0312-07 | Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. | Allergan Sales, LLC / 320,713 tubes | Class II | Terminated |
| D-1818-2015 | 08-24-2015 | Refresh P.M. (Mineral Oil 42.5% and White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt. 0.12 oz (3.5 g) tube, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612, NDC 0023-0240-04, UPC 3 00230 66704 3. Package NDCs: 0023-0240-21; 0023-0240-04; 0023-0667-04; 0023-0667-21 | Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product. | Allergan Sales, LLC / 1,154,359 tubes | Class II | Terminated |
| D-0965-2016 | 08-24-2015 | Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA. | Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements. | Novacare, LLC / N/A | Class I | Terminated |
| D-1154-2016 | 08-21-2015 | fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131 | Subpotent Drug | Cantrell Drug Company / 42 syringes | Class I | Terminated |
| D-0010-2016 | 08-21-2015 | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL Package NDCs: 0487-0201-01; 0487-0201-02; 0487-0201-03; 0487-0201-60 | Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process | Nephron Pharmaceuticals Corp. / a) 85,248 cartons and b) 35,292 cartons | Class II | Terminated |
| D-0389-2016 | 08-21-2015 | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01 | Discoloration | Nephron Pharmaceuticals Corp. / 32,490 cartons | Class II | Terminated |
| D-0295-2016 | 08-21-2015 | Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10 | Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled. | Akorn, Inc. / 13,896 bottles | Class III | Terminated |
| D-1160-2016 | 08-21-2015 | HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163 | Stability Data Does Not Support Expiry | Cantrell Drug Company / 4170 syringes | Class II | Terminated |
| D-1159-2016 | 08-21-2015 | HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212 | Stability Data Does Not Support Expiry | Cantrell Drug Company / 352 syringes | Class II | Terminated |
| D-1153-2016 | 08-21-2015 | Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453 | Subpotent Drug | Cantrell Drug Company / a) 450 syringes and b) 1250 syringes | Class I | Terminated |
| D-1161-2016 | 08-21-2015 | LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033 | Subpotent Drug | Cantrell Drug Company / 450 syringes | Class II | Terminated |
| D-1156-2016 | 08-21-2015 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR | Subpotent Drug | Cantrell Drug Company / a) 564 syringes and b) 1146 syringes | Class I | Terminated |
| D-1163-2016 | 08-21-2015 | MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721 | Subpotent Drug | Cantrell Drug Company / 212 syringes | Class II | Terminated |
| D-1416-2015 | 08-21-2015 | Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70 | Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17). | Silarx Pharmaceutical, Inc. / 576 bottles | Class III | Terminated |
| D-1162-2016 | 08-21-2015 | Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455 | Subpotent Drug | Cantrell Drug Company / 3853 syringes | Class II | Terminated |
| D-1155-2016 | 08-21-2015 | fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301 | Subpotent Drug | Cantrell Drug Company / 235 syringes | Class I | Terminated |
| D-1152-2016 | 08-21-2015 | fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450 | Subpotent Drug | Cantrell Drug Company / 884 syringes | Class I | Terminated |
| D-1158-2016 | 08-21-2015 | fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165 | Subpotent Drug | Cantrell Drug Company / 1652 syringes | Class I | Terminated |
| D-1164-2016 | 08-21-2015 | MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161 | Subpotent Drug | Cantrell Drug Company / 1570 syringes | Class II | Terminated |
| D-1157-2016 | 08-21-2015 | fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491 | Subpotent Drug | Cantrell Drug Company / 148 syringes | Class I | Terminated |
| D-0388-2016 | 08-21-2015 | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10 | Discoloration | Nephron Pharmaceuticals Corp. / 47,754 cartons | Class II | Terminated |
| D-0231-2016 | 08-20-2015 | RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42. | Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity. | Akorn, Inc. / 6861 Vials | Class III | Terminated |
| D-0418-2015 | 08-20-2015 | Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05 | Defective Container: There were customer complaints of cracked and leaking glass vials. | Hospira Inc. / 83,320 vials | Class II | Terminated |
| D-0589-2016 | 08-19-2015 | Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Subpotent drug. | Pharmakon Pharmaceuticals / 1150 | Class II | Terminated |
| D-0604-2016 | 08-19-2015 | Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 400 | Class II | Terminated |
| D-0599-2016 | 08-19-2015 | Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 1530 | Class II | Terminated |
| D-0596-2016 | 08-19-2015 | Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 7100 | Class II | Terminated |
| D-0609-2016 | 08-19-2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / N/A | Class II | Terminated |
| D-0592-2016 | 08-19-2015 | Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 2750 | Class II | Terminated |
| D-0602-2016 | 08-19-2015 | Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 250 | Class II | Terminated |
| D-0593-2016 | 08-19-2015 | Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Subpotent drug. | Pharmakon Pharmaceuticals / 210 | Class II | Terminated |
| D-0601-2016 | 08-19-2015 | Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 525 | Class II | Terminated |
| D-0605-2016 | 08-19-2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 378 | Class II | Terminated |
| D-0597-2016 | 08-19-2015 | Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 475 | Class II | Terminated |
| D-0588-2016 | 08-19-2015 | Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 4123 | Class II | Terminated |
| D-0606-2016 | 08-19-2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / N/A | Class II | Terminated |
| D-0594-2016 | 08-19-2015 | Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 4100 | Class II | Terminated |
| D-0598-2016 | 08-19-2015 | Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / 8000 | Class II | Terminated |
| D-0607-2016 | 08-19-2015 | Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. | Stability data does not support expiry. | Pharmakon Pharmaceuticals / N/A | Class II | Terminated |
