Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance
For Immediate Release
September 20, 2016
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Announcement
Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.
The recalled products were used for a variety of indications. NO VIAL OR PORTION OF ANY LOT OF THESE MEDICATIONS HAS BEEN FOUND TO BE NON STERILE. All recalled products have a label that includes the name Wells Pharmacy Network, logo, drug name, and expiration date. If unsure, Customers can call the pharmacy to determine if their product is on the list. To date, no adverse events have been reported.
WPN takes the utmost care to ensure patient safety. All patients and providers that received any sterile compounded products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry, should take the following actions:
- Discontinue use of the products;
- Quarantine any unused product until further instructions are received on how to return the product; and
- Contact WPN at the Quality hotline at (800) 794-2360 Monday through Friday, between 9:00 am and 6:00 pm EST or email at WPNQuality@wellsrx.com to discuss the return of any unused sterile product.
Adverse reactions or quality problems experienced with the use of these products in humans or animals may be reported to FDA in the following ways:
- For adverse
events in Humans please use FDA’s MedWatch Adverse Event Reporting
program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- For reporting animal adverse drug events, please follow the link to the FORM FDA 1932a found at: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm
Again, WPN’s primary concern is your safety and WPN is taking this action out of an abundance of caution. Thank you for your support.
List of products to be recalled:
| Drug | Lot # | Animal Type |
|---|---|---|
| TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE | 03282016@10 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE | 03282016@16 | Human |
| ULTRA-TEST 250 (CYP 80%/PROP 20%) 250MG/ML INJECTABLE | 03282016@22 | Human |
| TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE | 03282016@3 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE | 03282016@6 | Human |
| QUAD3 (2ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE | 03292016@12 | Human |
| PHENYLEPHRINE HCL - (5ML) 1MG/ML (0.1%) INJECTABLE | 03292016@3 | Human |
| MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE | 03292016@5 | Human |
| NICOTINAMIDE ADENINE DINUCLEOTIDE (NADH) - LYOPHILIZED (P.F.) 100MG INJECTABLE | 03302016@13 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE | 03302016@4 | Human |
| ULTRA-TEST 200 (8ML) GRAPESEED OIL (CYP 90%/PROP 10%) 200MG/ML INJECTABLE | 03302016@5 | Human |
| TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE | 03302016@6 | Human |
| METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE | 03302016@8 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML) 15MG/30MG/30MG/85MG/20MG/ML INJECTABLE | 03302016@9 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL | 03312016@1 | Human |
| ALPROSTADIL - (5ML) 20MCG/ML INJECTABLE | 03312016@6 | Human |
| TRIMIX - (10ML) 30MG / 2MG / 20MCG INJECTABLE | 03312016@7 | Human |
| QUAD2 (5ML) 9MG/1MG/10MCG/0.1MG/ML INJECTABLE | 03312016@8 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL (10ML) 210MG/ML INJECTABLE | 03312016@9 | Human |
| TESTOSTERONE CYPIONATE/ZINC SULFATE IN GRAPESEED 200MG/200MCG/ML INJECTABLE | 04012016@2 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (3ML) 200MG/ML INJECTABLE | 04012016@4 | Human |
| BIMIX - (5ML) 30MG/1MG INJECTABLE | 04012016@7 | Human |
| TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE | 04012016@9 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 200MG/ML INJECTABLE | 04042016@10 | Human |
| TESTOSTERONE PROPIONATE 100MG/ML INJECTABLE | 04042016@2 | Human |
| TRIMIX WITH ATROPINE (2ML) 30MG/3MG/150MCG/0.2MG/ML INJECTABLE | 04042016@22 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 11,000 UNIT VIAL VIAL | 04042016@30 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 200MG/ML INJECTABLE | 04042016@7 | Human |
| METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE | 04052016@1 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (1ML) 50MG/ML INJECTABLE | 04052016@4 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE | 04052016@5 | Human |
| MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE | 04062016@106 | Human |
| SERMORELIN ACETATE/GHRP (2) 6MG/4.5MG KIT | 04062016@170 | Human |
| LEUCINE/ISOLEUCINE/VALINE 10MG/10MG/5MG/ML INJECTABLE | 04062016@3 | Human |
| SODIUM BICARBONATE, MDV 8.4% INJECTABLE | 04062016@4 | Human |
| METHYLCOBALAMIN - 10ML 1,000MCG/ML INJECTABLE | 04062016@5 | Human |
| HISTRELIN ACETATE, LYOPHILIZED 5.5MG INJECTABLE | 04062016@6 | Vet |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL VIAL | 04062016@7 | Human |
| TRI1 - NR (2ML) 3.6MG/0.4MG/0.04MG INJECTABLE | 04072016@10 | Human |
| TRIMIX - (10ML) 30MG / 1MG / 10MCG INJECTABLE | 04072016@13 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMP+CARN+LIDO (30ML) 15MG/30MG/30MG/85MG/20MG/ML INJECTABLE | 04072016@15 | Human |
| SERMORELIN ACETATE/GHRP (2) & (6) 9MG/9MG/9MG KIT | 04072016@19 | Human |
| QUAD4 (2ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE | 04072016@8 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL (1ML) 200MG/ML INJECTABLE | 04072016@85 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMPLEX - (30ML) 15MG/50MG/100MG/ML INJECTABLE | 04082016@3 | Human |
| METHIONINE/INOSITOL/CHOLINE/B-COMP/(M)/CHROMIUM/CARNITINE 20MG/40MG/50MG/25MCG/25MG/ML INJECTABLE | 04082016@4 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE | 04082016@6 | Human |
| PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE | 04082016@7 | Vet |
| QUAD3 (5ML) 30MG/3MG/30MCG/0.1MG/ML INJECTABLE | 04112016@10 | Human |
| TRIMIX WITH ATROPINE (10ML) 30MG/3MG/150MCG/0.2MG/ML INJECTABLE | 04112016@13 | Human |
| NANDROLONE DECANOATE (H) 200MG/ML INJECTABLE | 04112016@16 | Human |
| VITAMIN D3 IN SESAME OIL (5ML) 100,000 IU/ML INJECTABLE | 04112016@23 | Human |
| TRIMIX / ATROPINE (10ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE | 04112016@6 | Human |
| TRI2 - NR (5ML) 30MG/3MG/0.3MG INJECTABLE | 04112016@8 | Human |
| TESTOSTERONE CYPIONATE/ANASTROZOLE 200MG/1MG/ML INJECTABLE | 04122016@1 | Human |
| QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE | 04122016@17 | Human |
| TRIMIX (10ML) 30MG/3MG/100MCG INJECTABLE | 04122016@18 | Human |
| TRI1 - NR (5ML) 3.6MG/0.4MG/0.04MG INJECTABLE | 04122016@19 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE | 04122016@2 | Human |
| TRI-TEST 200 (CEP) 200MG/ML INJECTABLE | 04122016@4 | Human |
| MIC COMBO - STANDARD (30ML) 15MG/50MG/100MG/ML INJECTABLE | 04122016@76 | Human |
| TESTOSTERONE ENANTHATE-GRAPESEED OIL 200MG/ML INJECTABLE | 04132016@1 | Human |
| TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE | 04132016@14 | Human |
| INOSITOL/CHOLINE/B-COMP+LEUCINE+CARN+CHROM+LIDO 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE | 04132016@32 | Human |
| DMSO W/LIDOCAINE 50%/0.5% SOLUTION | 04132016@69 | Human |
| TITAN UP (INOS/CHOL/LEUC/CARN/CHROM/LIDO) 25MG/25MG/1.5MG/25MG/25MCG/10MG INJECTABLE | 04132016@8 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 3,500 UNIT VIAL VIAL | 04132016@91 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 20,000 UNIT VIAL VIAL | 04132016@96 | Human |
| MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC | 04142016@107 | Human |
| METHYLCOBALAMIN - 30ML 1,000MCG/ML INJECTABLE | 04142016@112 | Human |
| QUAD1 (2ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE | 04142016@14 | Human |
| QUAD1 (5ML) 0.9MG/0.2MG/20MCG/0.01MG/ML INJECTABLE | 04142016@15 | Human |
| QUAD4 (5ML) 30MG/3MG/60MCG/0.2MG/ML INJECTABLE | 04142016@16 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (10ML) 200MG/ML INJECTABLE | 04142016@2 | Human |
| SERMORELIN ACETATE 28MG KIT | 04142016@28 | Human |
| CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 6,000 UNIT VIAL VIAL | 04142016@34 | Human |
| SERMORELIN ACETATE 15MG KIT | 04142016@43 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 20MG/ML INJECTABLE | 04142016@5 | Human |
| TESTOSTERONE CYPIONATE IN GRAPE SEED OIL (5ML) 100MG/ML INJECTABLE | 04142016@7 | Human |
| SERMORELIN ACETATE/GHRP (2) 9MG/3MG KIT | 04152016@149 | Human |
| ULTRA-TEST 200 - (10ML VIAL) 200MG/ML INJECTABLE | 04152016@2 | Human |
| SERMORELIN ACETATE/GHRP (2) 9MG/9MG KIT | 04152016@21 | Human |
| METHYLCOBALAMIN 5,000MCG/ML INJECTABLE | 04152016@3 | Human |
| METHIONINE/INOSITOL/CHOLINE/CHROMIUM+B12(M) - 10ML 25MG/50MG/50MG/25MCG/1MG/ML INJECTABLE | 04152016@5 | Human |
| MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE | 04182016@10 | Human |
| TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE | 04182016@33 | Human |
| METHIONINE/INO |
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